Keynote Session
Dr Borges
Borges VF. Options for endocrine-refractory, hormone receptor-positive breast cancer: Which target and when? J Clin Oncol 2021;39(35):3890-6. Abstract
Buller W et al. CDK4/6 inhibitors in metastatic breast cancer, a comparison of toxicity and efficacy across agents in a real-world dataset. J Oncol Pharm Pract 2023;29(8):1825-35. Abstract
Johnston S et al. Abemaciclib as initial therapy for advanced breast cancer: MONARCH 3 updated results in prognostic subgroups. NPJ Breast Cancer 2021;7(1):80. Abstract
Kalinsky K et al. Abemaciclib plus fulvestrant in advanced breast cancer after progression on CDK4/6 inhibition: Results from the phase III postMONARCH trial. J Clin Oncol 2024:[Online ahead of print]. Abstract
Kappel C et al. Comparative overall survival of CDK4/6 inhibitors in combination with endocrine therapy in advanced breast cancer. Sci Rep 2024;14(1):3129. Abstract
Lu Y-S et al. Final results of RIGHT Choice: Ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol 2024;42(23):2812-21. Abstract
Sonke GS et al. Early versus deferred use of CDK4/6 inhibitors in advanced breast cancer. Nature 2024;636(8042):474-80. Abstract
Dr Burstein
André F et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: Final overall survival results from SOLAR-1. Ann Oncol 2021;32(2):208-17. Abstract
André F et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380(20):1929-40. Abstract
Baselga J et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366(6):520-9. Abstract
Burstein HJ. Systemic therapy for estrogen receptor-positive, HER2-negative breast cancer. N Engl J Med 2020;383(26):2557-70. Abstract
Hortobagyi GN et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016;375(18):1738-48. Abstract
Howell SJ et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive, HER2-negative breast cancer (FAKTION): Overall survival, updated progression-free survival, and expanded biomarker analysis from a randomised, phase 2 trial. Lancet Oncol 2022;23(7):851-64. Abstract
Jones RH et al. Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in metastatic, oestrogen receptor-positive breast cancer (FAKTION): A multicentre, randomised, controlled, phase 2 trial. Lancet Oncol 2020;21(3):345-57. Abstract
Juric D et al. First-line inavolisib/placebo + palbociclib + fulvestrant (Inavo/Pbo+Palbo+Fulv) in patients (pts) with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer who relapsed during/within 12 months (mo) of adjuvant endocrine therapy completion: INAVO120 phase III randomized trial additional analyses. ASCO 2024;Abstract 1003.
Oliveira M et al. A randomised phase 2 trial of neoadjuvant multi-agent chemotherapy (CHT) or patritumab deruxtecan (HER3-DXd; U3-1402) +/- endocrine therapy (ET) for high-risk hormone receptor positive (HR+/HER2-) early breast cancer (EBC): SOLTI-2103 VALENTINE trial. ESMO Breast Cancer Congress 2023;Abstract 155TiP.
Turner NC et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med 2024;391(17):1584-96. Abstract
Turner NC et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med 2023;388(22):2058-70. Abstract
Dr O’Shaughnessy
Bardia A et al. Elacestrant in ER+, HER2- metastatic breast cancer with ESR1-mutated tumors: Subgroup analyses from the phase III EMERALD trial by prior duration of endocrine therapy plus CDK4/6 inhibitor and in clinical subgroups. Clin Cancer Res 2024;30(19):4299-309. Abstract
Bardia A et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting. San Antonio Breast Cancer Symposium 2022;Abstract GS3-01.
Bidard F et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: Results from the randomized phase III EMERALD trial. J Clin Oncol 2022;40(28):3246-56. Abstract
Jhaveri K et al. Imlunestrant, an oral selective estrogen receptor degrader (SERD), as monotherapy & combined with abemaciclib, for patients with ER+, HER2- advanced breast cancer (ABC), pretreated with endocrine therapy (ET): Results of the phase 3 EMBER-3 trial. San Antonio Breast Cancer Symposium 2024;Abstract GS1-01.
Kaklamani VG et al. Oral elacestrant vs standard-of-care in estrogen receptor-positive, HER2-negative (ER+/HER2-) advanced or metastatic breast cancer (mBC) without detectable ESR1 mutation (EMERALD): Subgroup analysis by prior duration of CDK4/6i plus endocrine therapy (ET). ASCO 2023;Abstract 1070.
Kolberg H-C A et al. Comparison of an atezolizumab monotherapy window followed by atezolizumab and chemotherapy vs. atezolizumab and chemotherapy alone in triple negative breast cancer (TNBC) – Final analysis of the neoadjuvant neoMono trial. San Antonio Breast Cancer Symposium 2023;Abstract PS16-01.
Martín M et al. Giredestrant for estrogen receptor-positive, HER2-negative, previously treated advanced breast cancer: Results from the randomized, phase II acelERA breast cancer study. J Clin Oncol 2024;42(18):2149-60. Abstract
Martín M et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase II, randomised, open-label acelERA BC study. ESMO 2022;Abstract 211MO.
Oliveira M et al. Camizestrant, a next-generation oral SERD, versus fulvestrant in post-menopausal women with oestrogen receptor-positive, HER2-negative advanced breast cancer (SERENA-2): A multi-dose, open-label, randomised, phase 2 trial. Lancet Oncol 2024;25(11):1424-39. Abstract
Oliveira M et al. Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: Results of the randomized, multi-dose phase 2 SERENA-2 trial. San Antonio Breast Cancer Symposium 2022;Abstract GS3-02.
Rugo HS et al. Elacestrant in various combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (adv/mBC): Preliminary data from ELEVATE, a phase 1b/2, open-label, umbrella study. ASCO 2024;Abstract 1069.
Turner NC et al. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 2020;21(10):1296-308. Abstract
Dr Bardia
Bardia A et al. Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: Primary results from TROPION-Breast01. J Clin Oncol 2025;43(3):285-96. Abstract
Bardia A et al. Trastuzumab deruxtecan after endocrine therapy in metastatic breast cancer. N Engl J Med 2024;391(22):2110-22. Abstract
Bardia A et al. Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer (BC): Primary results from the randomised phase III TROPION-Breast01 trial. ESMO 2023;Abstract LBA11.
Coates JT et al. Parallel genomic alterations of antigen and payload targets mediate polyclonal acquired clinical resistance to sacituzumab govitecan in triple-negative breast cancer. Cancer Discov 2021;11(10):2436-45. Abstract
Curigliano G et al. Short-term risk of recurrence in patients (pts) with HR+/HER2− early breast cancer (EBC) treated with endocrine therapy (ET) in randomized clinical trials (RCTs): A meta-analysis. ASCO 2024;Abstract 541.
Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Updated survival results of the randomized, phase III DESTINY-Breast04 study. ESMO 2023;Abstract 376O.
Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study. ASCO 2022;Abstract LBA3.
Rugo HS et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): A randomised, open-label, multicentre, phase 3 trial. Lancet 2023;402(10411):1423-33. Abstract
Rugo HS et al. Trastuzumab deruxtecan (T-DXd) vs treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): A detailed safety analysis of the randomized, phase 3 DESTINY-Breast04 trial. ESMO Breast Cancer Congress 2023;Abstract 185O.
Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2022;40(29):3365-76. Abstract
Module 1: HER2-Positive, Triple-Negative and Localized Breast Cancer
Dr O’Shaughnessy
Chan A et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer 2021;21(1):80-91.e7. Abstract
Cortés J et al. Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer. N Engl J Med 2022;386(12):1143-54. Abstract
Cortés J et al. Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast cancer (mBC): Results of the randomized phase III DESTINY-Breast03 study. ESMO 2021;Abstract LBA1.
Freedman RA et al. TBCRC 022: A phase II trial of neratinib and capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases. J Clin Oncol 2019;37(13):1081-9. Abstract
Geyer CE et al. Trastuzumab deruxtecan (T-DXd; DS-8201) vs trastuzumab emtansine (T-DM1) in high-risk patients with HER2-positive, residual invasive early breast cancer after neoadjuvant therapy: A randomized, phase 3 trial (DESTINY-Breast05). San Antonio Breast Cancer Symposium 2020;Abstract OT-03-01.
Harbeck N et al. Trastuzumab deruxtecan in HER2-positive advanced breast cancer with or without brain metastases: A phase 3b/4 trial. Nat Med 2024;30(12):3717-27. Abstract
Hurvitz SA et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: Updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. Lancet 2023;401(10371):105-17. Abstract
Hurvitz S et al. Trastuzumab deruxtecan (T-DXd; DS-8201a) vs. trastuzumab emtansine (T-DM1) in patients (pts) with HER2+ metastatic breast cancer (mBC): Subgroup analyses from the randomized phase 3 study DESTINY-Breast03. San Antonio Breast Cancer Symposium 2021;Abstract GS3-01.
Lin NU et al. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol 2020;38(23):2610-9. Abstract
Loibl S et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. San Antonio Breast Cancer Symposium 2024;Abstract GS03-12.
Metzger O et al. AFT-38 PATINA: A randomized, open label, phase III trial to evaluate the efficacy and safety of palbociclib + anti-HER2 therapy + endocrine therapy vs. anti-HER2 therapy + endocrine therapy after induction treatment for hormone receptor-positive (HR+)/HER-positive metastatic breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS2-12.
Weiss A et al. Nodal positivity and systemic therapy among patients with clinical T1-T2N0 human epidermal growth factor receptor-positive breast cancer: Results from two international cohorts. Cancer 2023;129(12):1836-45. Abstract
Dr Bardia
Bardia A et al. Final results from the randomized phase III ASCENT clinical trial in metastatic triple-negative breast cancer and association of outcomes by human epidermal growth factor receptor 2 and trophoblast cell surface antigen 2 expression. J Clin Oncol 2024;42(15):1738-44. Abstract
Bardia A et al. Sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): Final results from the phase 3 ASCENT study. ASCO 2022;Abstract 1071.
Cortes J et al. Pembrolizumab plus chemotherapy in advanced triple-negative breast cancer. N Engl J Med 2022;387(3):217-26. Abstract
Dent RA et al. TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer. Future Oncol 2023;19(35):2349-59. Abstract
Garber J et al. OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients w/ germline BRCA1 & BRCA2 pathogenic variants & highrisk HER2-negative primary breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS1-09.
Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med 2022;387(1):9-20. Abstract
Modi S et al. Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study. ASCO 2022;Abstract LBA3.
Rugo H et al. KEYNOTE-355: Final results from a randomized, double-blind phase III study of first-line pembrolizumab + chemotherapy vs placebo + chemotherapy for metastatic TNBC. ESMO 2021;Abstract LBA16.
Schmid P et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. ESMO 2024;Abstract LBA4.
Schmid P et al. TROPION-Breast05: Phase (Ph) III study of datopotamab deruxtecan (Dato-DXd) ± durvalumab (D) vs chemotherapy (CT) + pembrolizumab (pembro) in patients (pts) with PD-L1+ locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). ESMO Breast 2024;Abstract 261TiP.
Schmid P et al. Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Updated results from BEGONIA, a phase Ib/II study. ESMO 2023;Abstract 379MO.
Tung NM et al. TBCRC 048 (olaparib expanded) expansion cohorts: Phase 2 study of olaparib monotherapy in patients (pts) with metastatic breast cancer (MBC) with germline (g) mutations in PALB2 or somatic (s) mutations in BRCA1 or BRCA2. ASCO 2024;Abstract 1021.
Turner N et al. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment. Future Oncol 2023;19(8):559-73. Abstract
Tutt A et al. OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER2-negative early breast cancer. ASCO 2021;Abstract LBA1.
Dr Borges
Cardoso F et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016;375(8):717-29. Abstract
Chen N et al. impact of anthracyclines in high genomic risk node-negative HR+/HER2- breast cancer. San Antonio Breast Cancer Symposium 2024;Abstract GS3-03.
Clement Z et al. Extended duration of adjuvant aromatase inhibitor in breast cancer: A meta-analysis of randomized controlled trials. Gland Surg 2018;7(5):449-57. Abstract
Francis PA et al. Adjuvant endocrine therapy in premenopausal breast cancer: 12-year results from SOFT. J Clin Oncol 2023;41(7):1370-5. Abstract
Francis PA et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med 2018;379(2):122-37. Abstract
Gray RG et al. Effects of ovarian ablation or suppression on breast cancer recurrence and survival: Patient-level meta-analysis of 14,993 pre-menopausal women in 25 randomized trials. ASCO 2023;Abstract 503.
Gray R et al. Effects of prolonging adjuvant aromatase inhibitor therapy beyond five years on recurrence and cause-specific mortality: An EBCTCG meta-analysis of individual patient data from 12 randomised trials including 24,912 women. San Antonio Breast Cancer Symposium 2019;Abstract GS3-03.
Kalinsky K et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med 2021;385(25):2336-47. Abstract
Oktay K et al. Fertility preservation in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol 2018;36(19):1994-2001. Abstract
Pagani O et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer: Long-term follow-up of the combined TEXT and SOFT trials. J Clin Oncol 2023;41(7):1376-82. Abstract
Piccart M et al. 70-gene signature as an aid for treatment decisions in early breast cancer: Updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol 2021;22(4):476-88. Abstract
Sparano JA et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379(2):111-21. Abstract
Dr Burstein
Barrios CH et al. NATALEE update: Safety and treatment (tx) duration of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2- early breast cancer (EBC). ESMO Breast 2024;Abstract 113MO.
Fasching PA et al. Health-related quality of life (HRQoL) in the phase III NATALEE study of adjuvant ribociclib (RIB) plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone in patients (pts) with HR+/HER2− early breast cancer (EBC). ESMO 2023;Abstract VP3-2023.
Gnant M et al. Adjuvant palbociclib for early breast cancer: The PALLAS trial results (ABCSG-42/AFT-05/BIG-14-03). J Clin Oncol 2022;40(3):282-93. Abstract
Hamilton EP et al. Efficacy and safety results by age in monarchE: Adjuvant abemaciclib combined with endocrine therapy (ET) in patients with HR+, HER2-, node-positive, high-risk early breast cancer (EBC). ASCO 2023;Abstract 501.
Harbeck N et al. Long-term patient-reported outcomes from monarchE: Abemaciclib plus endocrine therapy for adjuvant HR+, HER2-, node-positive, high-risk, early breast cancer (EBC). ESMO Breast 2023;Abstract 93MO.
Hurvitz SA et al. Potent cell-cycle inhibition and upregulation of immune response with abemaciclib and anastrozole in neoMONARCH, phase II neoadjuvant study in HR+/HER2- breast cancer. Clin Cancer Res 2020;26(3):566-80. Abstract
Johnston SRD et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): Results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol 2023;24(1):77-90. Abstract
Loibl S et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer—The Penelope-B trial. J Clin Oncol 2021;39(14):1518-30. Abstract
Loibl S et al. Phase III study of palbociclib combined with endocrine therapy (ET) in patients with hormone-receptor-positive (HR+), HER2-negative primary breast cancerand with high relapse risk after neoadjuvant chemotherapy (NACT): First results from PENELOPE-B. San Antonio Breast Cancer Symposium 2020;Abstract GS1-02.
Mayer EL et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol 2021;22(2):212-22. Abstract
Rugo HS et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: Safety and patient-reported outcomes from the monarchE study. Ann Oncol 2022;33(6):616-27. Abstract
Slamon DJ et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer: Primary results from the phase III NATALEE trial. ASCO 2023;Abstract LBA500.
Tarantino P et al. Quantitative standardized high sensitivity (HS)-HER2 testing predicts outcomes with trastuzumab deruxtecan (T-DXd) for metastatic breast cancer (MBC). ESMO 2024;Abstract 394P.
Module 2: Neuroendocrine Tumors
Dr Singh
Caplin ME et al. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med 2014;371(3):224-33. Abstract
Hijioka S et al. A phase III study of combination therapy with everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (JCOG1901, STARTER-NET). Gastrointestinal Cancers Symposium 2025;Abstract 652.
Rinke A et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: A report from the PROMID Study Group. J Clin Oncol;27(28):4656-63. Abstract
Singh S et al. [177Lu]Lu-DOTA-TATE in newly diagnosed patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors: Primary analysis of the phase 3 randomized NETTER-2 study. Gastrointestinal Cancers Symposium 2024;Abstract LBA588.
Singh S et al. First-line efficacy of [177Lu]Lu-DOTA-TATE in patients with advanced grade 2 and grade 3, well-differentiated gastroenteropancreatic neuroendocrine tumors by tumor grade and primary origin: Subgroup analysis of the phase III NETTER-2 study. ESMO Gastrointestinal Cancers Congress 2024;Abstract 211MO.
Dr Strosberg
Al-Toubah T et al. Efficacy of FOLFOX in patients with aggressive pancreatic neuroendocrine tumors after prior capecitabine/temozolomide. Oncologist 2021;26(2):115-9. Abstract
Cao Y et al. Favorable response to immunotherapy in a pancreatic neuroendocrine tumor with temozolomide‐induced high tumor mutational burden. Cancer Commun (Lond) 2020;40(12):746-51. Abstract
Chan J et al. Cabozantinib versus placebo for advanced neuroendocrine tumors (NET) after progression on prior therapy (CABINET Trial/Alliance A021602): Updated results including progression free-survival (PFS) by blinded independent central review (BICR) and subgroup analyses. ESMO 2024;Abstract 1141O.
Chan JA et al. Phase 3 trial of cabozantinib to treat advanced neuroendocrine tumors. N Engl J Med 2025;392(7):653-65. Abstract
Cordero-Hernandez IS et al. Transformation of G1-G2 neuroendocrine tumors (NETs) to neuroendocrine carcinomas (NECs) following peptide receptor radionuclide therapy (PRRT): A case series. NANETS 2022;Abstract 21416.
Strosberg JR et al. Risk of bowel obstruction in patients with mesenteric or peritoneal disease receiving peptide receptor radionuclide therapy. J Nucl Med 2021;62(1):69-72. Abstract
Module 3: Chronic Lymphocytic Leukemia
Dr Lamanna
Ahn IE et al. Ibrutinib for chronic lymphocytic leukemia with TP53 alterations. N Engl J Med 2020;383(5):498-500. Abstract
Al-Sawaf O et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study. Blood 2024;144(18):1924-35. Abstract
Al-Sawaf O et al. Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia. Nat Commun 2023;14(1):2147. Abstract
Barr PM et al. Up to 8-year follow-up from RESONATE-2: First-line ibrutinib treatment for patients with chronic lymphocytic leukemia. Blood Adv 2022;6(11):3440-50. Abstract
Brown JR et al. Sustained benefit of zanubrutinib vs ibrutinib in patients with R/R CLL/SLL: Final comparative analysis of ALPINE. Blood 2024;144(26):2706-17. Abstract
Byrd JC et al. Acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia: Results of the first randomized phase III trial. J Clin Oncol 2021;39(31):3441-52. Abstract
Davids MS et al. Contribution of obinutuzumab to acalabrutinib therapy in patients with treatment-naive chronic lymphocytic leukemia: Analysis of survival outcomes by genomic features. ASH 2022;Abstract 1815.
Döhner H et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med 2000;343(26):1910-6. Abstract
Shadman M et al. Sustained superiority of zanubrutinib vs bendamustine + rituximab in treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL): 5-year follow-up of cohort 1 from the SEQUOIA study. ASH 2024;Abstract 3249.
Shanafelt TD et al. Long-term outcomes for ibrutinib-rituximab and chemoimmunotherapy in CLL: Updated results of the E1912 trial. Blood 2022;140(2):112-20. Abstract
Sharman JP et al. Acalabrutinib ± obinutuzumab vs obinutuzumab + chlorambucil in treatment-naive chronic lymphocytic leukemia: 6-year follow-up of Elevate-TN. ASH 2023;Abstract 636.
Sharman JP et al. Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN. ASCO 2022;Abstract 7539.
Tam CS et al. SEQUOIA: Results of a phase 3 randomized study of zanubrutinib versus bendamustine + rituximab (BR) in patients with treatment-naïve (TN) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). ASH 2021;Abstract 396.
Woyach JA et al. A041702: A randomized phase III study of ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (≥ 70 years of age) with chronic lymphocytic leukemia (CLL). ASH 2021;Abstract 639.
Woyach JA et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med 2018;379(26):2517-28. Abstract
Dr Rogers
Brown JR et al. Fixed-duration acalabrutinib combinations in untreated chronic lymphocytic leukemia. N Engl J Med 2025;392(8):748-62. Abstract
Brown JR et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: Interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. ASH 2024;Abstract 1009.
Guo W-H et al. Enhancing intracellular accumulation and target engagement of PROTACs with reversible covalent chemistry. Nat Commun 2020;11(1):4268. Abstract
Ma S et al. Combination of zanubrutinib + venetoclax for treatment-naive (TN) CLL/SLL with del(17p) and/or TP53: Preliminary results from SEQUOIA arm D. EHA 2024;Abstract S160.
Patten PEM et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naive CLL. ASH 2024;Abstract 3257.1.
Rogers K et al. 7-year update on a phase 2 trial of fixed-duration obinutuzumab, ibrutinib, and venetoclax for CLL. EHA 2024;Abstract S162.
Sharman JP et al. BRUIN CLL-321: Randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in BTK inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. ASH 2024;Abstract 886.
Siddiqi T et al. Lisocabtagene maraleucel (liso-cel) in patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Updated follow-up of Transcend CLL 004. ASH 2024;Abstract 4633.
Siddiqi T et al. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): A multicentre, open-label, single-arm, phase 1-2 study. Lancet 2023;402(10402):641-54. Abstract
Soumerai JD et al. Sonrotoclax and zanubrutinib as frontline treatment for CLL demonstrates high MRD clearance rates with good tolerability: Data from an ongoing phase 1/1b study BGB-11417-101. ASH 2024;Abstract 1012.
Thompson MC et al. Preliminary efficacy and safety of the Bruton tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: Results from the phase 1 CaDAnCe-101 study. ASH 2024;Abstract 885.
Wierda WG et al. Lisocabtagene maraleucel (liso-cel) combined with ibrutinib (ibr) for patients (pts) with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary results from the open-label, phase 1/2 Transcend CLL 004 study. ASH 2024;Abstract 887.
Wierda WG et al. Outcomes in high-risk subgroups after fixed-duration ibrutinib + venetoclax for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Up to 5.5 years of follow-up in the phase 2 CAPTIVATE study. ASCO 2024;Abstract 7009.
Woyach JA et al. Results of a phase 3 study of IVO vs IO for previously untreated older patients (pts) with chronic lymphocytic leukemia (CLL) and impact of COVID-19 (Alliance). ASCO 2023;Abstract 7500.
Module 4: Sarcoma and Other Connective Tissue Neoplasms
Dr Chugh
Gelderblom H et al. Vimseltinib versus placebo for tenosynovial giant cell tumour (MOTION): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2024;403(10445):2709-19. Abstract
Gounder M. Nirogacestat for desmoid tumors. ASCO 2024;Educational Session.
Gounder M et al. Nirogacestat, a γ-secretase inhibitor for desmoid tumors. N Engl J Med 2023;388(10):898-912. Abstract
Moertel CL et al. ReNeu: A pivotal phase 2b trial of mirdametinib in children and adults with neurofibromatosis type 1 (NF1)-associated symptomatic inoperable plexiform neurofibroma (PN). ASCO 2024;Abstract 3016.
Napolitano A et al. Recent advances in desmoid tumor therapy. Cancers (Basel) 2020;12(8):2135. Abstract
Niu X et al. MANEUVER: A phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients. Future Oncol 2024:1-8. Abstract
Spierenburg G et al. Tenosynovial giant cell tumors (TGCT): Molecular biology, drug targets and non-surgical pharmacological approaches. Expert Opin Ther Targets 2022;26(4):333-45. Abstract
Tap WD et al. Efficacy, safety, and patient-reported outcomes of vimseltinib in patients with tenosynovial giant cell tumor: Results from the phase 3 MOTION trial. ASCO 2024;Abstract 11500.
Tap WD et al. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): A randomised phase 3 trial. Lancet 2019;394(10197):478-87. Abstract
Van Der Graaf WTA et al. Impact of nirogacestat on pain, a key symptom in patients with desmoid tumors (DT): Results from the phase 3 DeFi study. ASCO 2023;Abstract 11564.
Vincenzi B et al. Efficacy of nirogacestat in patients with desmoid tumors and poor prognostic factors: Patient-reported outcomes, progression-free survival, and objective response rate in the phase 3 DeFi trial. CTOS 2024;Paper 102.
Dr Riedel
Chawla SP et al. Results of the phase 1b soft-tissue sarcoma (STS) portion of the global randomized, double-blind, placebo-controlled study of tazemetostat (TAZ) plus doxorubicin (DOX) as frontline therapy for advanced epithelioid sarcoma (ES). ASCO 2021;Abstract 11563.
Damerell V et al. Molecular mechanisms underpinning sarcomas and implications for current and future therapy. Signal Transduct Target Ther 2021;6(1):246. Abstract
D’Angelo SP et al. Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): An international, open-label, phase 2 trial. Lancet 2024;403(10435):1460-71. Abstract
D’Angelo SP et al. Planned analysis of the pivotal IGNYTE-ESO trial of lete-cel in patients with synovial sarcoma or myxoid/round cell liposarcoma. CTOS 2024;Paper 84.
Gounder M et al. Tazemetostat in advanced epithelioid sarcoma with loss of INI1/SMARCB1: An international, open-label, phase 2 basket study. Lancet Oncol 2020;21(11):1423-32. Abstract
Hong DS et al. Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: A phase 1 trial. Nat Med 2023;29(1):104-14. Abstract
Module 5: EGFR Mutation-Positive Non-Small Cell Lung Cancer
Prof Leighl
Besse B et al. Mechanisms of acquired resistance to first-line amivantamab plus lazertinib versus osimertinib in patients with EGFR-mutant advanced non-small cell lung cancer: An early analysis from the phase III MARIPOSA study. ESMO 2024;Abstract LBA55.
Cho BC et al. Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med 2024;391(16):1486-98. Abstract
Cho BC et al. Enhanced vs standard dermatologic management with amivantamab-lazertinib in advanced NSCLC: Phase 2 COCOON study. WCLC 2024;Abstract P3.12D.04.
Cho BC et al. Amivantamab plus lazertinib vs osimertinib as first-line treatment in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results from MARIPOSA, a phase III, global, randomized, controlled trial. ESMO 2023;Abstract LBA14.
Gadgeel S et al. Amivantamab plus lazertinib vs osimertinib in first-line EGFR-mutant advanced NSCLC: Longer follow-up of the MARIPOSA study. WCLC 2024;Abstract OA02.03.
Herbst RS et al. Overall survival analysis from the ADAURA trial of adjuvant osimertinib in patients with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). ASCO 2023;Abstract LBA3.
Janne P et al. Osimertinib with/without platinum-based chemotherapy as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA2). WCLC 2023;Abstract PL03.13.
John T et al. Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). ASCO 2024;Abstract 8005.
Lee CK et al. Acquired mechanisms of resistance to first-line (1L) osimertinib with or without platinum-based chemotherapy (CT) in EGFR-mutated (EGFRm) advanced NSCLC: Preliminary data from FLAURA2. ESMO Asia Congress 2023;Abstract 514MO.
Leighl NB et al. Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. ASCO 2024;Abstract LBA8505.
Leighl NB et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: Primary results from the phase III PALOMA-3 study. J Clin Oncol 2024;42(30):3593-605. Abstract
Lopes et al. Preventing infusion-related reactions with intravenous amivantamab: Primary results from SKIPPirr, a phase 2 study. WCLC 2024;Abstract MA12.08.
Lu S et al. Osimertinib after chemoradiotherapy in stage III EGFR-mutated NSCLC. N Engl J Med 2024;391(7):585-97. Abstract
Passaro A et al. Amivantamab plus chemotherapy (with or without lazertinib) vs chemotherapy in EGFR-mutated advanced NSCLC after progression on osimertinib: MARIPOSA-2, a phase III, global, randomized, controlled trial. ESMO 2023;Abstract LBA15.
Planchard D et al. Encorafenib plus binimetinib in patients (pts) with previously untreated BRAF V600E-mutant advanced non-small cell lung cancer (NSCLC): An open-label, multicenter phase II trial (IFCT-1904 ENCO-BRAF). ESMO 2024;Abstract 1259MO.
Planchard D et al. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med 2023;389(21):1935-48. Abstract
Ramalingam SS et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. ASCO 2024;Abstract LBA4.
Valdiviezo Lama NI et al. First-line (1L) osimertinib (osi) ± platinum-pemetrexed in EGFR-mutated (EGFRm) advanced NSCLC: FLAURA2 post-progression outcomes. ELCC 2024;Abstract 4O.
Dr Goldman
Ahn M-J et al. A phase I/II study of davutamig (REGN5093), a MET×MET bispecific antibody, in patients with MET-altered, advanced non-small cell lung cancer (aNSCLC): Trial in progress update. ESMO Asia Congress 2024;Abstract 721TiP.
Camidge DR et al. Phase I study of 2- or 3-week dosing of telisotuzumab vedotin, an antibody–drug conjugate targeting c-Met, monotherapy in patients with advanced non–small cell lung carcinoma. Clin Cancer Res 2021;27(21):5781-92. Abstract
Garrido Lopez P et al. Long-term efficacy, safety, and predictors of response to amivantamab among patients with post-platinum EGFR Ex20ins-mutated advanced NSCLC. ELCC 2023;Abstract 3O.
Goldman JW et al. Phase 1/1b study of telisotuzumab vedotin (Teliso-V) + osimertinib (Osi), after failure on prior Osi, in patients with advanced, c-Met overexpressing, EGFR-mutated non-small cell lung cancer (NSCLC). ASCO 2022;Abstract 9013.
Han B et al. A phase 1b study of furmonertinib, an oral, brain penetrant, selective EGFR Inhibitor, in patients with advanced NSCLC with EGFR exon 20 insertions. WCLC 2023;Abstract OA03.04.
Mok T et al. HERTHENA-Lung02: Phase III study of patritumab deruxtecan in advanced EGFR-mutated NSCLC after a third-generation EGFR TKI. Future Oncol 2024;20(15):969-80. Abstract
Park K et al. Amivantamab in EGFR exon 20 insertion-mutated non-small-cell lung cancer progressing on platinum chemotherapy: Initial results from the CHRYSALIS phase I study. J Clin Oncol 2021;39(30):3391-402. Abstract
Piotrowska Z et al. Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions. J Clin Oncol 2023;41(26):4218-25. Abstract
Ramalingam SS et al. Phase I/II study of mobocertinib in EGFR exon 20 insertion (ex20ins) + metastatic NSCLC (mNSCLC): Updated results from platinum-pretreated patients (PPP). ESMO 2022;Abstract 988P.
Wang M et al. Sunvozertinib for the treatment of NSCLC with EGFR exon20 insertion mutations: The first pivotal study results. ASCO 2023;Abstract 9002.
Xu Y et al. Efficacy and safety of sunvozertinib in treatment naïve NSCLC patients with EGFR exon20 insertion mutations. ASCO 2023;Abstract 9073.
Yu HA et al. Patritumab deruxtecan (HER3-DXd) in EGFR-mutated NSCLC following EGFRTKI and platinum-based chemotherapy: HERTHENA-Lung01.WCLC 2023;Abstract OA05.03.
Zhou C et al. Amivantamab plus chemotherapy in NSCLC with EGFRexon 20 insertions. N Engl J Med 2023;389(22):2039-51. Abstract
Module 6: Gynecologic Cancers
Dr O’Malley
Chase DM et al. Impact of disease progression on health-related quality of life of advanced ovarian cancer patients - Pooled analysis from the PRIMA trial. Gynecol Oncol 2022;166(3):494-502. Abstract
González-Martín A et al. Final overall survival (OS) in patients (pts) with newly diagnosed advanced ovarian cancer (aOC) treated with niraparib (nir) first-line (1L) maintenance: Results from PRIMA/ENGOT-OV26/GOG-3012. ESMO 2024;Abstract LBA29.
Harter P et al. Durvalumab with paclitaxel/carboplatin (PC) and bevacizumab (bev), followed by maintenance durvalumab, bev, and olaparib in patients (pts) with newly diagnosed advanced ovarian cancer (AOC) without a tumor BRCA1/2 mutation (non-tBRCAm): Results from the randomized, placebo (pbo)-controlled phase III DUO-O trial. ASCO 2023;Abstract LBA5506.
Kristeleit R et al. Interim post-progression data and updated survival in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO. SGO 2024;Abstract 07.
Lee JY et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: results from the cervical, endometrial, and ovarian cancer cohorts of the destiny-PanTumor02 study. IGCS 2023;Abstract 1550.
Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract
Monk B et al. ATHENA-COMBO, a phase III, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients (pts) with newly diagnosed ovarian cancer (OC). ESMO 2024;Abstract LBA30.
Moore KN et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer. N Engl J Med 2023;389(23):2162-74. Abstract
Moore KN et al. Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer (OVC): Subgroup analysis of a first-in-human phase I study. ESMO 2023;Abstract 745MO.
Ray-Coquard I et al. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: Final overall survival results from the PAOLA-1/ENGOT-ov25 trial. Ann Oncol 2023;34(8):681-92. Abstract
Secord AA et al. PICCOLO: An open-label, single arm, phase 2 study of mirvetuximab soravtansine in recurrent platinum sensitive, high-grade epithelial ovarian cancers with high folate-alpha expression. IGCS 2022;Abstract 1556.
Secord AA et al. PICCOLO: An open-label, single arm, phase 2 study of mirvetuximab soravtansine in recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate-alpha (FRα) expression. SGO 2022;Abstract 300.
Trillsch F et al. Durvalumab (D) + carboplatin/paclitaxel (CP) + bevacizumab (B) followed by D, B + olaparib (O) maintenance (mtx) for newly diagnosed advanced ovarian cancer (AOC) without a tumour BRCA1/BRCA2 mutation (non-tBRCAm): Updated results from DUO-O. ESMO Gynecologic Cancers Congress 2024;Abstract 43O.
Uzunparmak B et al. HER2-low expression in patients with advanced or metastatic solid tumors. Ann Oncol 2023;34(11):1035-46. Abstract
Vergote I et al. Chemotherapy with or without pembrolizumab followed by maintenance with olaparib or placebo for first-line treatment of advanced BRCA non-mutated epithelial ovarian cancer: Results from the randomized phase 3 ENGOT-OV43/GOG-3036/KEYLYNK-001 study. ESGO 2025;Abstract
Dr Slomovitz
Colombo N et al.Atezolizumab and chemotherapy for advanced or recurrent endometrial cancer (AtTEnd): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2024;25(9):1135-46. Abstract
Colombo N et al. Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma. Ann Oncol 2023;34(suppl 2):S1281-2. Abstract LBA40.
Eskander RN et al. Pembrolizumab plus chemotherapy in advanced endometrial cancer. N Engl J Med 2023;388(23):2159-70. Abstract
Lorusso D et al. Pembrolizumab plus chemotherapy for advanced and recurrent cervical cancer: Final analysis according to bevacizumab use in the randomized KEYNOTE-826 study. Ann Oncol 2025;36(1):65-75. Abstract
Lorusso D et al. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): A randomised, double-blind, phase 3 clinical trial. Lancet 2024;403(10434):1341-50. Abstract
Lorusso D et al. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): Overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2024;404(10460):1321-32. Abstract
Makker V et al. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study. Gynecol Oncol 2024:185:202-11. Abstract
Miller DS et al. Carboplatin and paclitaxel for advanced endometrial cancer: Final overall survival and adverse event analysis of a phase III trial (NRG Oncology/GOG0209). J Clin Oncol 2020;38(33):3841-50. Abstract
Mirza MR et al. Progression-free survival (PFS) in primary advanced or recurrent endometrial cancer (pA/rEC) in the overall and mismatch repair proficient (MMR/MSS) populations and in histological and molecular subgroups: Results from part 2 of the RUBY trial. ESMO Gynecological Cancers Congress 2024;Abstract 38MO.
Mirza MR et al. Dostarlimab + chemotherapy for the treatment of primary advanced or recurrent endometrial cancer (pA/rEC): Analysis of progression free survival (PFS) and overall survival (OS) outcomes by molecular classification in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. ESMO 2023;Abstract 740MO.
Mirza MR et al. Dostarlimab for primary advanced or recurrent endometrial cancer. N Engl J Med 2023;388(23):2145-58. Abstract
Mirza MR et al. Dostarlimab in combination with chemotherapy for the treatment of primary advanced or recurrent endometrial cancer: A placebo-controlled randomized phase 3 trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). IGCS 2023;Abstract 1309.
Slomovitz BM et al. Long-term follow up of selinexor maintenance in patients with TP53wt advanced or recurrent endometrial cancer: A pre-specified subgroup analysis from the phase 3 ENGOT-EN5/GOG-3055/SIENDO study. J Clin Oncol 2023;41(suppl 36):427956. Abstract
Vergote I et al. Oral selinexor as maintenance therapy after first-line chemotherapy for advanced or recurrent endometrial cancer. J Clin Oncol 2023;41(35):5400-10. Abstract
Westin SN et al. Durvalumab plus carboplatin/paclitaxel followed by maintenance durvalumab with or without olaparib as first-line treatment for advanced endometrial cancer: The phase III DUO-E trial. J Clin Oncol 2024;42(3):283-99. Abstract
Module 7: Prostate Cancer
Dr Oh
Aggarwal R et al. PRESTO: A phase III, open-label study of intensification of androgen blockade in patients with high-risk biochemically relapsed castration-sensitive prostate cancer (AFT-19). J Clin Oncol 2024;42(10):1114-23. Abstract
Armstrong AJ et al. Improved survival with enzalutamide in patients with metastatic hormone-sensitive prostate cancer. J Clin Oncol 2022;40(15):1616-22. Abstract
Chi KN et al. Final analysis results from TITAN: A phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). Genitourinary Cancers Symposium 2021;Abstract 11.
Fizazi K et al. A phase III trial of capivasertib and abiraterone versus placebo and abiraterone in patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency (CAPItello-281). Genitourinary Cancers Symposium 2021;Abstract TPS178.
Fizazi K et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): Final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol 2019;20(5):686-700. Abstract
Freedland SJ et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med 2023;389(16):1453-65. Abstract
Hussain M et al. Metastatic hormone-sensitive prostate cancer and combination treatment outcomes: A review. JAMA Oncol 2024;10(6):807-20. Abstract
Saad F et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J Clin Oncol 2024;42(36):4271-81. Abstract
Saad F et al. Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial. ESMO 2024;Abstract LBA68.
Smith MR et al. Overall survival with darolutamide versus placebo in combination with androgen-deprivation therapy and docetaxel for metastatic hormone-sensitive prostate cancer in the phase 3 ARASENS trial. Genitourinary Cancers Symposium 2022;Abstract 13.
Dr Aggarwal
Agarwal N et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA18.
Agarwal N et al. Cabozantinib (C) plus atezolizumab (A) versus 2nd novel hormonal therapy (NHT) in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC): Final overall survival (OS) results of the phase III, randomized, CONTACT-02 study. ESMO 2024;Abstract LBA67.
Agarwal N et al. CONTACT-02: Phase 3 study of cabozantinib (C) plus atezolizumab (A) vs second novel hormonal therapy (NHT) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Genitourinary Cancers Symposium 2024;Abstract 18.
Chi K et al. Phase 3 MAGNITUDE study: First results of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) as first-line therapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) with and without homologous recombination repair (HRR) gene alterations. Genitourinary Cancers Symposium 2022;Abstract 12.
Fizazi K et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line (1L) treatment in patients (pts) with homologous recombination repair (HRR)-deficient metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Genitourinary Cancers Symposium 2025;Abstract LBA141.
Gillessen S et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. ESMO 2024;Abstract LBA1.
Kelly WK et al. Xaluritamig, a STEAP1 x CD3 XmAb 2+1 immune therapy, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Initial results from dose expansion cohorts in a phase I study. ESMO 2024;Abstract 1598P.
Morris M et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): A phase 3, randomised, controlled trial. Lancet 2024;404(10459):1227-39. Abstract
Morris M et al. Phase III study of lutetium-177-PSMA-617 in patients with metastatic castration-resistant prostate cancer (VISION). ASCO 2021;Abstract LBA4.
Panebianco M et al. Combination of the PARPi and ARSi in advanced castration resistant prostate cancer: A review of the recent phase III trials. Explor Target Antitumor Ther 2024;5(5):997-1010. Abstract
Saad F et al. Olaparib plus abiraterone versus placebo plus abiraterone in metastatic castration-resistant prostate cancer (PROpel): Final prespecified overall survival results of a randomised, double-blind, phase 3 trial. Lancet Oncol 2023;24(10):1094-108. Abstract
Saad F et al. PROpel: Phase III trial of olaparib (ola) and abiraterone (abi) versus placebo (pbo) and abi as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Genitourinary Cancers Symposium 2022;Abstract 11.
Sartor O et al. Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore). ESMO 2023;Abstract LBA13.
Schweizer MT et al. Mevrometostat (PF-06821497), an enhancer of zeste homolog 2 (EZH2) inhibitor, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC): A randomized dose-expansion study. Genitourinary Cancers Symposium 2025;Abstract LBA138.
Shore N et al. Real-world genetic testing patterns in metastatic castration-resistant prostate cancer. Future Oncol 2021;17(22):2907-21. Abstract
Module 8: Biliary Tract Cancers
Dr Mahipal
Goyal L et al. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med 2023;388(3):228-39. Abstract
Harding JJ et al. HERIZON-BTC-302: A phase 3 study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC). Gastrointestinal Cancers Symposium 2025;Abstract TPS648.
Harding JJ et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): A multicentre, single-arm, phase 2b study. Lancet Oncol. 2023 Jul;24(7):772-782. Abstract
Ikeda M et al. Randomized, open-label, multicenter, phase III study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care (SOC) in first-line, human epidermal growth factor receptor 2 (HER2)-expressing, locally advanced or metastatic (LA/m) biliary tract cancer (BTC): DESTINY-BTC01. ESMO Asia Congress 2024;Abstract 261TiP.
Meric-Bernstam et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract
Naleid N et al. Utilization of circulating tumor DNA (ctDNA) testing in biliary tract cancers. Gastrointestinal Cancers Symposium 2025;Abstract 644.
Pant S et al. Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study. ASCO 2024;Abstract 4091.
Vogel A et al. An open-label study of pemigatinib in cholangiocarcinoma: Final results from FIGHT-202. ESMO Open 2024;9(6):103488. Abstract
Dr Borad
Azad AA et al. Sequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): A multicentre, open-label, randomised, phase 2 study. Lancet Oncol 2024;25(10):1267-76. Abstract
Finn RS et al. Pembrolizumab (pembro) in patients (pts) with sorafenib-treated (cohort 1) and treatment (tx)-naive (cohort 2) advanced hepatocellular carcinoma (aHCC) after additional follow-up in the phase 2 KEYNOTE-224 study. ASCO 2024;Abstract 4100.
Kelley RK et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2023;401(10391):1853-65. Abstract
Lamarca A et al. ABC-06 | A randomised phase III, multi-centre, open-label study of active symptom control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy. ASCO 2019;Abstract 4003.
Oh D et al. Safety of 30 min infusion of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in first-line treatment (tx) of advanced biliary tract cancer (aBTC): TOURMALINE early results. ESMO 2024;Abstract 1330.
Oh D-Y et al. Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer. NEJM Evid 2022;1(8). Abstract
Valle J et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 2010;362(14):1273-81. Abstract
Yoo C et al. Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic biliary tract cancer (BTC) after progression on gemcitabine plus cisplatin (GemCis): Multicenter comparative randomized phase 2b study (NIFTY). ASCO 2021;Abstract 4006.
Module 9: Non-Hodgkin Lymphoma
Dr Patel
Abramson J et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) for relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL): Results of a global randomized phase III trial (STARGLO). EHA 2024;Abstract LB3438.
Abramson JS et al. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood 2024;143(5):404-16. Abstract
Abramson JS et al. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: Primary analysis of the phase 3 TRANSFORM study. Blood 2023;141(14):1675-84. Abstract
Crump M et al. Outcomes in refractory diffuse large B-cell lymphoma: Results from the international SCHOLAR-1 study. Blood 2017;130(16):1800-8. Abstract
Dickinson MJ et al. Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med 2022;387(24):2220-31. Abstract
Dreyling M et al. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update. Blood 2024;143(17):1713-25. Abstract
Hutchings M et al. Glofitamab monotherapy in relapsed or refractory large B-cell lymphoma: Extended follow-up from a pivotal phase II study and subgroup analyses in patients with prior chimeric antigen receptor T-cell therapy and by baseline total metabolic tumor volume. ASH 2023;Abstract 433.
Karimi Y et al. Extended follow-up results beyond 2.5 years from the pivotal NHL-1 EPCORE trial: Subcutaneous epcoritamab monotherapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). ASCO 2024;Abstract 7039.
Kim TM et al. Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma. Ann Oncol 2024;35(11):1039-47. Abstract
Link BK et al. Second-line and subsequent therapy and outcomes for follicular lymphoma in the United States: Data from the observational national LymphoCare study. Br J Haematol 2019;184(4):660-3. Abstract
Linton KM et al. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): A phase 2 cohort of a single-arm, multicentre study. Lancet Haematol 2024;11(8):e593-605. Abstract
Matasar M et al. Efficacy and safety of odronextamab monotherapy in patients (Pts) with diffuse large B-cell lymphoma (DLBCL) progressing after CAR T-cell therapy: Primary analysis from the ELM-1 study. ASH 2024;Abstract 866.
Morschhauser F et al. Lisocabtagene maraleucel in follicular lymphoma: The phase 2 TRANSCEND FL study. Nat Med 2024;30(8):2199-207. Abstract
Neelapu SS et al. Three-year follow-up analysis of axicabtagene ciloleucel in relapsed/refractory indolent non-Hodgkin lymphoma (ZUMA-5). Blood 2024;143(6):496-506. Abstract
Neelapu SS et al. Five-year follow-up of ZUMA-1 supports the curative potential of axicabtagene ciloleucel in refractory large B-cell lymphoma. Blood 2023;141(19):2307-15. Abstract
Phillips T et al. Glofitamab monotherapy in patients with heavily pretreated relapsed or refractory mantle cell lymphoma: Updated analysis from a phase I/II study. EHA 2024;Abstract S231.
Schuster SJ et al. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): A multicentre, open-label, single-arm, phase 2 study. Lancet Oncol 2021;22(10):1403-15. Abstract
Sehgal AR et al. Lisocabtagene maraleucel as second-line therapy for R/R large B-cell lymphoma in patients not intended for hematopoietic stem cell transplant: Final analysis of the phase 2 PILOT study. ASH 2023;Abstract 105.
Sehn LH et al. Long-term 3-year follow-up of mosunetuzumab in relapsed or refractory follicular lymphoma after ≥2 prior therapies. Blood 2025;145(7):708-19. Abstract
Thieblemont C et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large B-cell lymphoma: Dose expansion in a phase I/II trial. J Clin Oncol 2023;41(12):2238-47. Abstract
Wang M et al. Three-year follow-up of KTE-X19 in patients with relapsed/refractory mantle cell lymphoma, including high-risk subgroups, in the ZUMA-2 study. J Clin Oncol 2023;41(3):555-67. Abstract
Westin JR et al. Survival with axicabtagene ciloleucel in large B-cell lymphoma. N Engl J Med 2023;389(2):148-57. Abstract
Dr Flowers
Caimi PF et al. Loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma: Long-term efficacy and safety from the phase II LOTIS-2 study. Haematologica 2024;109(4):1184-93. Abstract
Dreyling M et al. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): A three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. Lancet 2024;403(10441):2293-306. Abstract
Duell J et al. Tafasitamab for patients with relapsed or refractory diffuse large B-cell lymphoma: Final 5-year efficacy and safety findings in the phase II L-MIND study. Haematologica 2024;109(2):553-66. Abstract
Jain P et al. Acalabrutinib with rituximab is highly effective first line treatment for older patients with mantle cell lymphoma. ASH 2024;Abstract 3038.
Jain P et al. Ibrutinib with rituximab in first-line treatment of older patients with mantle cell lymphoma. J Clin Oncol 2022;40(2):202-12. Abstract
Kumar A et al. Zanubrutinib, obinutuzumab, and venetoclax for first-line treatment of mantle cell lymphoma with a TP53 mutation. Blood 2025;145(5):497-507. Abstract
Lewis DJ et al. Ibrutinib-rituximab is superior to rituximab-chemotherapy in previously untreated older mantle cell lymphoma patients: Results from the international randomised controlled trial, Enrich. ASH 2024;Abstract 235.
Salles G et al. Five-year analysis of the POLARIX study: Prolonged follow-up confirms positive impact of polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) on outcomes. ASH 2024;Abstract 469.
Salles G et al. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): A multicentre, prospective, single-arm, phase 2 study. Lancet Oncol 2020;21(7):978-88. Abstract
Sehn LH et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: Results from a phase 3 study (inMIND). ASH 2024;Abstract LBA-1.
Sehn LH et al. Polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory diffuse large B-cell lymphoma: Updated results of a phase Ib/II randomized study and preliminary results of a single-arm extension. ASH 2020;Abstract 3020.
Tilly H et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma.N Engl J Med 2022;386(4):351-63. Abstract
Wang M et al. Acalabrutinib plus bendamustine and rituximab in untreated mantle cell lymphoma: Results from the phase 3, double-blind, placebo-controlled ECHO trial. EHA 2024;Abstract LB3439.
Module 10: Colorectal Cancer
Dr Lieu
Cercek A et al. Durable complete responses to PD-1 blockade alone in mismatch repair deficient locally advanced rectal cancer. ASCO 2024;Abstract LBA3512.
Cercek A et al. PD-1 blockade in mismatch repair-deficient, locally advanced rectal cancer. N Engl J Med 2022;386(25):2363-76. Abstract
Chalabi M et al. Neoadjuvant immunotherapy in locally advanced MMR-deficient colon cancer: 3-year disease-free survival from NICHE-2. ESMO 2024;Abstract LBA24.
Chalabi M et al. Neoadjuvant immune checkpoint inhibition in locally advanced MMR-deficient colon cancer: The NICHE-2 study. ESMO 2022;Abstract LBA7.
Kasi PM et al. Patient-reported outcomes from the BESPOKE CRC study. Gastrointestinal Cancers Symposium 2024;Abstract 54.
Kasi PM et al. BESPOKE study protocol: A multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer. BMJ Open 2021;11(9). Abstract
Nowak JA et al. Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG-80702. Gastrointestinal Cancers Symposium 2025;Abstract LBA14.
Shah P et al. Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort. Gastrointestinal Cancers Symposium 2025;Abstract 15.
Tie et al. Adjuvant chemotherapy guided by circulating tumor DNA analysis in stage II colon cancer: The randomized DYNAMIC trial. ASCO 2022;Abstract LBA100.
Dr Raghav
André T et al. First results of nivolumab (NIVO) plus ipilimumab (IPI) vs NIVO monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) from CheckMate 8HW. Gastrointestinal Cancers Symposium 2025;Abstract LBA143.
André T et al. Pembrolizumab versus chemotherapy in microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer: 5-year follow-up from the randomized phase III KEYNOTE-177 study. Ann Oncol 2025;36(3):277-84. Abstract
André T et al. Nivolumab plus ipilimumab in microsatellite-instability–high metastatic colorectal cancer. N Engl J Med 2024;391(21):2014-26. Abstract
André T et al. Pembrolizumab in microsatellite-instability–high advanced colorectal cancer. N Engl J Med 2020;383(23):2207-18. Abstract
Cremolini C et al. Individual patient data meta-analysis of FOLFOXIRI plus bevacizumab versus doublets plus bevacizumab as initial therapy of unresectable metastatic colorectal cancer. J Clin Oncol 2020:JCO2001225. Abstract
Cremolini C et al. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: Updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study. Lancet Oncol 2015;16(13):1306-15. Abstract
Dasari A et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): An international, multicentre, randomised, double-blind, phase 3 study. Lancet 2023;402(10395):41-53. Abstract
Diaz LA et al. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): Final analysis of a randomised, open-label, phase 3 study. Lancet Oncol 2022;23(5):659-70. Abstract
Fakih MG et al. Sotorasib plus panitumumab in refractory colorectal cancer with mutated KRAS G12C. N Engl J Med 2023;389(23):2125-39. Abstract
Kopetz S et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: A randomized phase 3 trial. Nat Med 2025;[Online ahead of print]. Abstract
Lenz HJ et al. First-line nivolumab plus low-dose ipilimumab for microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer: The phase II CheckMate 142 study. J Clin Oncol 2022;40(2):161-70. Abstract
Li J et al. Effect of fruquintinib vs placebo on overall survival in patients with previously treated metastatic colorectal cancer: The FRESCO randomized clinical trial. JAMA 2018;319(24):2486-96. Abstract
Raghav KPS et al. Trastuzumab plus pertuzumab versus cetuximab plus irinotecan in patients with RAS/BRAF wild-type, HER2-positive, metastatic colorectal cancer (S1613): A randomized phase II trial. J Clin Oncol 2025:JCO2401710. Abstract
Raghav KPS et al. Trastuzumab deruxtecan in patients with HER2-positive advanced colorectal cancer (DESTINY-CRC02): Primary results from a multicentre, randomised, phase 2 trial. Lancet Oncol 2024;25(9):1147-62. Abstract
Strickler JH et al. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER). ASCO 2024;Abstract 3509.
Strickler JH et al. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): A multicentre, open-label, phase 2 study. Lancet Oncol 2023;24(5):496-508. Abstract
Yaeger R et al. Efficacy and safety of adagrasib plus cetuximab in patients with KRASG12C-mutated metastatic colorectal cancer. Cancer Discov 2024;14(6):982-93. Abstract
Yaeger R et al. Adagrasib with or without cetuximab in colorectal cancer with mutated KRAS G12C. N Engl J Med 2023;388(1):44-54. Abstract
Module 11: Urothelial Bladder Cancer
Dr Gupta
Apolo AB et al. Adjuvant pembrolizumab versus observation in muscle-invasive urothelial carcinoma. N Engl J Med 2025;392(1):45-55. Abstract
Apolo AB et al. AMBASSADOR Alliance A031501: Phase III randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma (MIUC) vs observation. Genitourinary Cancers Symposium 2024;Abstract LBA531.
Balar AV et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): An open-label, single-arm, multicentre, phase 2 study. Lancet Oncol 2021;22(7):919-30. Abstract
Daneshmand S et al. First results from SunRISe-1 in patients with BCG unresponsive high-risk non–muscle-invasive bladder cancer receiving TAR-200 in combination with cetrelimab, TAR-200, or cetrelimab alone. AUA 2023;Abstract LBA02-03.
Daneshmand S et al. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: A phase I trial. Urol Oncol 2022;40(7):344.e1-344.e9. Abstract
Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract
Grimberg DC et al. Overview of Taris GemRIS, a novel drug delivery system for bladder cancer. Eur Urol Focus 2020;6(4):620-2. Abstract
Necchi A et al. Pembrolizumab monotherapy for high-risk non-muscle-invasive bladder cancer without carcinoma in situ and unresponsive to BCG (KEYNOTE-057): A single-arm, multicentre, phase 2 trial. Lancet Oncol 2024;25(6):720-30. Abstract
Necchi A et al. TAR-200 in patients with bacillus Calmette–Guérin-unresponsive high-risk non–muscle-invasive bladder cancer: Results from SunRISe-1 study. AUA 2024;Abstract P2-01.
Necchi A et al. Results from SunRISe-1 in patients (pts) with bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC) receiving TAR-200 monotherapy. ESMO 2023;Abstract LBA105.
Powles T et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.
Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract
Tyson MD et al. Safety, tolerability, and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer who refused or were unfit for curative-intent therapy: A phase 1 study. J Urol 2023;209(5):890-900. Abstract
Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. AUA 2024;Abstract PD48-02.
Dr Rosenberg
Galsky MD et al. A phase 3, open-label, randomized study of nivolumab plus ipilimumab or standard of care (SOC) versus SOC alone in patients (pts) with previously untreated unresectable or metastatic urothelial carcinoma (mUC; CheckMate 901). ASCO 2018;Abstract TPS539.
Gupta S et al. Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up. ASCO 2023;Abstract 4505.
Iyer G et al. A first-in-human phase 1 study of LY3866288 (LOXO-435), a potent, highly isoform-selective FGFR3 inhibitor (FGFR3i) in advanced solid tumors with FGFR3 alterations: Initial results from FORAGER-1. Genitourinary Cancers Symposium 2025;Abstract 662.
Loriot Y et al. Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma. N Engl J Med 2023;389(21):1961-71. Abstract
Ma Y et al. BL-B01D1, a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, in patients with locally advanced or metastatic solid tumours: A first-in-human, open-label, multicentre, phase 1 study. Lancet Oncol 2024;25(7):901-11. Abstract
Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract
O’Donnell PH et al. Enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial cancer. J Clin Oncol 2023;41(25):4107-17. Abstract
Powles T et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Genitourinary Cancers Symposium 2025;Abstract 664.
Powles T et al. EV-302: Exploratory analysis of nectin-4 expression and response to 1L enfortumab vedotin (EV) + pembrolizumab (P) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). ESMO 2024;Abstract 1966MO.
Powles T et al. Avelumab first-line maintenance for advanced urothelial carcinoma: Results from the JAVELIN Bladder 100 trial after ≥2 years of follow-up. J Clin Oncol 2023;41(19):3486-92. Abstract
Powles T et al. EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). ESMO 2023;Abstract LBA6.
Powles T et al. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Genitourinary Cancers Symposium 2022;Abstract 487.
Powles T et al. Enfortumab vedotin in previously treated advanced urothelial carcinoma. N Engl J Med 2021;384(12):1125-35. Abstract
Siefker-Radtke AO et al. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: Cohort 2 of the randomized phase III THOR trial. Ann Oncol 2024;35(1):107-17. Abstract
van der Heijden M et al. Nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: Results from the phase III CheckMate 901 trial. ESMO 2023;Abstract LBA7.
Wan W et al. BL-B01D1, a novel EGFR×HER3-targeting ADC, demonstrates robust anti-tumor efficacy in preclinical evaluation. AACR 2023;Abstract 2642.
Zhang A et al. A multicenter, open-label phase 1/2 study of TYRA-300 in advanced urothelial carcinoma and other solid tumors with activating FGFR3 gene alterations (SURF301). EORTC-NCI-AACR Symposium;Abstract PB023.
Module 12: Multiple Myeloma
Dr Callander
Badros A et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: The AURIGA study. Blood 2025;145(3):300-10. Abstract
Dimopoulos MA et al. Daratumumab or active monitoring for high-risk smoldering multiple myeloma. N Engl J Med 2024;[Online ahead of print]. Abstract
Dimopoulos M-A et al. Phase 3 randomized study of daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: Primary results of the Aquila study. ASH 2024;Abstract 773.
Facon T et al. Isatuximab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2024;391(17):1597-609. Abstract
Facon T et al. Phase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). ASCO 2024;Abstract 7500.
Gasparetto C et al. Once weekly selinexor, carfilzomib and dexamethasone in carfilzomib non-refractory multiple myeloma patients. Br J Cancer 2022;126(5):718-25. Abstract
Grosicki S et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): A randomised, open-label, phase 3 trial. Lancet 2020;396(10262):1563-73. Abstract
Jagannath S et al. Association of selinexor dose reductions with clinical outcomes in the BOSTON study. Clin Lymphoma Myeloma Leuk 2023;23(12):917-23.e3. Abstract
Leleu XP et al. Phase 3 randomized study of isatuximab (Isa) plus lenalidomide and dexamethasone (Rd) with bortezomib versus IsaRd in patients with newly diagnosed transplant ineligible multiple myeloma (NDMM TI). ASCO 2024;Abstract 7501.
Martin T et al. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: Updated results from IKEMA, a randomized phase 3 study. Blood Cancer J 2023;13(1):72. Abstract
Moreau P et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: Long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol 2024;25(8):1003-14. Abstract
Richardson PG et al. Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: Final overall survival analysis. Haematologica 2024;109(7):2239-49. Abstract
Rodriguez-Otero P et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. ASCO 2024;Abstract 7502.
Sandhu I et al. Mezigdomide (MEZI) plus dexamethasone (DEX) and bortezomib (BORT) or carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Updated results from the CC-92480-MM-002 trial. ASH 2024;Abstract 1025.
Sonneveld P et al. Daratumumab, bortezomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2024 ;390(4):301-13. Abstract
Sonneveld P et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib, lenalidomide, and dexamethasone (VRd) versus VRd alone in patients (pts) with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplantation (ASCT): Primary results of the Perseus trial. ASH 2023;Abstract LBA-1.
Usmani S et al. Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: The randomized phase 3 CEPHEUS trial. Nat Med 2025;[Online ahead of print]. Abstract
Usmani S et al. Daratumumab + bortezomib/lenalidomide/dexamethasone in patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: Results of the phase 3 CEPHEUS study. IMS 2024;Abstract OA-63.
White D et al. Efficacy and safety of once weekly selinexor 40 mg versus 60 mg with pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Front Oncol 2024;14:1352281. Abstract
Dr Martin
Bahlis NJ et al. Talquetamab + daratumumab + pomalidomide in patients with relapsed/refractory multiple myeloma: Results from the phase 1b TRIMM-2 study. IMS 2024;Abstract OA-01.
Berdeja JG et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): A phase 1b/2 open-label study. Lancet 2021;398(10297):314-24. Abstract
Cohen Y et al. Talquetamab + teclistamab in patients with relapsed/refractory multiple myeloma: Updated phase 1b results from RedirecTT-1 with >1 year of follow-up. IMS 2024;Abstract OA-03.
Dimopoulos MA et al. Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone vs pomalidomide plus bortezomib and dexamethasone in relapsed/refractory multiple myeloma. EHA 2024;Abstract LB3440.
Garfall AL et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. ASCO 2024;Abstract 7540.
Hansen D et al. A comparison of standard of care idecabtagene vicleucel and ciltacabtagene autoleucel CAR T-cell therapy in relapsed or refractory multiple myeloma. IMS 2024;Abstract OA-07.
Lin Y et al. CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. ASCO 2023;Abstract 8009.
Martin T et al. Ciltacabtagene autoleucel, an anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy, for relapsed/refractory multiple myeloma: CARTITUDE-1 2-year follow-up. J Clin Oncol 2023;41(6):1265-74.Abstract
Mateos M-V et al. Results from DREAMM-7 a randomized phase 3 study of belantamab mafodotin + bortezomib, and dexamethasone vs daratumumab + bortezomib, and dexamethasone in relapsed/refractory multiple myeloma. EHA 2024;Abstract S214.
Prince HM et al. MagnetisMM-3: Long-term update and efficacy and safety of less frequent dosing of elranatamab in patients with relapsed or refractory multiple myeloma. ASH 2024;Abstract 4738.
Schinke CD et al. Pivotal phase 2 MonumenTAL-1 results of talquetamab (tal), a GPRC5D x CD3 bispecific antibody (BsAb), for relapsed/refractory multiple myeloma (RRMM). ASCO 2023;Abstract 8036.
Sidana S et al. Safety and efficacy of standard of care ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma (RRMM): Real world experience with updated follow-up. IMS 2024;Abstract OA-11.
Sidiqi MH et al. Efficacy and safety in patients with lenalidomide-refractory multiple myeloma after 1-3 prior lines who received a single infusion of ciltacabtagene autoleucel as study treatment in the phase 3 CARTITUDE-4 trial. ASH 2023;Abstract 4866.
Trudel S et al. Cevostamab monotherapy continues to show clinically meaningful activity and manageable safety in patients with heavily pre-treated relapsed/refractory multiple myeloma (RRMM): Updated results from an ongoing phase I study. ASH 2021;Abstract 157.
Module 13: Hepatocellular Carcinoma
Dr Abrams
Abou-Alfa GK et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. Gastrointestinal Cancers Symposium 2022;Abstract 379.
Finn RS et al. IMbrave150: Updated overall survival (OS) data from a global, randomized, open-label phase III study of atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in patients (pts) with unresectable hepatocellular carcinoma (HCC). Gastrointestinal Cancers Symposium 2021;Abstract 267.
Finn RS et al. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med 2020;382(20):1894-905. Abstract
Galle PR et al. Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line treatment for unresectable hepatocellular carcinoma (uHCC): First results from CheckMate 9DW. ASCO 2024;Abstract LBA4008.
Llovet JM et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359(4):378-90. Abstract
Qin S et al. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): A randomised, open-label, international phase 3 study. Lancet 2023;402(10408):1133-46. Abstract
Rimassa L et al. Five-year overall survival (OS) and OS by tumour response measures from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC). ESMO 2024;Abstract 947MO.
Dr Kaseb
Kaseb AO et al. Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: A randomised, open-label, phase 2 trial. Lancet Gastroenterol Hepatol 2022;7(3):208-18. Abstract
Kudo M et al. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): A multicentre, randomised, double-blind, phase 3 study. Lancet 2025;405(10474):203-15. Abstract
Lencioni R et al. EMERALD-1: A phase 3, randomized, placebo-controlled study of transarterial chemoembolization combined with durvalumab with or without bevacizumab in participants with unresectable hepatocellular carcinoma eligible for embolization. Gastrointestinal Cancers Symposium 2024;Abstract LBA432.
Lin H et al. Neoadjuvant radiotherapy provided survival benefit compared to adjuvant radiotherapy for hepatocellular carcinoma. ANZ J Surg 2018;88(10):E718-24. Abstract
Qin S et al. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): A randomised, open-label, multicentre, phase 3 trial. Lancet 2023;402(10415):1835-47. Abstract
Sangro B et al. Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): A multiregional, randomised, double-blind, placebo-controlled, phase 3 study. Lancet 2025;405(10474):216-32. Abstract
Tian C et al. Neoadjuvant immune checkpoint inhibitors in hepatocellular carcinoma: A meta-analysis and systematic review. Front Immunol 2024;15:1352873. Abstract
Yopp A et al. Updated efficacy and safety data from IMbrave050: Phase III study of adjuvant atezolizumab (atezo) + bevacizumab (bev) vs active surveillance in patients (pts) with resected or ablated high-risk hepatocellular carcinoma (HCC). ESMO 2024;Abstract LBA39.
Module 14: Systemic Mastocytosis and Myelofibrosis
Dr Bose
Castells M et al. HARBOR: A phase 2/3 study of BLU-263 in patients with indolent systemic mastocytosis and monoclonal mast cell activation syndrome. EHA 2022;Abstract P1017.
Dave N et al. CT122 – Safety and pharmacokinetics of BLU-263, a next-generation KIT inhibitor, in normal healthy volunteers. AACR 2021;Abstract CT122.
DeAngelo DJ et al. Apex part 1: Updated assessment of bezuclastinib (CGT9486), a selective KIT D816V tyrosine kinase inhibitor, in patients with advanced systemic mastocytosis (AdvSM). ASH 2024;Abstract 659.
DeAngelo DJ et al. Safety and efficacy of avapritinib in advanced systemic mastocytosis: The phase 1 EXPLORER trial. Nat Med 2021;27(12):2183-91. Abstract
Evans EK et al. A precision therapy against cancers driven by KIT/PDGFRA mutations. Sci Transl Med 2017;9(414). Abstract
Gotlib J et al. Avapritinib versus placebo in indolent systemic mastocytosis. NEJM Evid 2023;2(6). Abstract
Gotlib J et al. Efficacy and safety of avapritinib in advanced systemic mastocytosis: Interim analysis of the phase 2 PATHFINDER trial. Nat Med 2021;27(12):2192-9. Abstract
Rein LAM et al. Updated efficacy and safety results of patients receiving selected 100mg bezuclastinib dose and participating in the open-label extension of Summit: A randomized, double-blind, placebo controlled phase 2 clinical trial of bezuclastinib in adult patients with nonadvanced systemic mastocytosis. ASH 2024;Abstract 4556.
Reiter A et al. Avapritinib in patients with advanced systemic mastocytosis (ADVSM): Efficacy and safety analysis from the phase 2 PATHFINDER study with 3-year follow-up. EHA 2024;Abstract S224.
Reiter A et al. Efficacy and safety of avapritinib in previously treated patients with advanced systemic mastocytosis. Blood Adv 2022;6(21):5750-62. Abstract
Tashi T et al. Elenestinib, an investigational, next generation KIT D816V inhibitor, reduces mast cell burden, improves symptoms, and has a favorable safety profile in patients with indolent systemic mastocytosis: Analysis of the HARBOR trial. ASH 2023;Abstract 76.
Dr Kuykendall
Harrison CN et al. Efficacy and safety of fedratinib in patients with myelofibrosis previously treated with ruxolitinib (FREEDOM2): Results from a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Haematol 2024;11(10):e729-40. Abstract
Harrison C et al. MANIFEST-2, a global, phase 3, randomized, double-blind, active-control study of pelabresib (CPI-0610) and ruxolitinib vs placebo and ruxolitinib in JAK inhibitor-naïve myelofibrosis patients. EHA 2022;Abstract P1030.
Harrison CN et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. Am J Hematol 2020;95(6):594-603. Abstract
Harrison CN et al. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): A randomised, open-label, phase 3 trial. Lancet Haematol 2018;5(2):e73-81. Abstract
Maffioli M et al. A prognostic model to predict survival after 6 months of ruxolitinib in patients with myelofibrosis. Blood Adv 2022;6(6):1855-64. Abstract
Mascarenhas J et al. Pacritinib vs best available therapy, including ruxolitinib, in patients with myelofibrosis: A randomized clinical trial. JAMA Oncol 2018;4(5):652-9. Abstract
Mesa RA et al. SIMPLIFY-1: A phase III randomized trial of momelotinib versus ruxolitinib in Janus kinase inhibitor-naïve patients with myelofibrosis. J Clin Oncol 2017;35(34):3844-50. Abstract
Oh ST et al. Pacritinib is a potent ACVR1 inhibitor with significant anemia benefit in patients with myelofibrosis. Blood Adv 2023;7(19):5835-42. Abstract
Pardanani A et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: A randomized clinical trial. JAMA Oncol 2015;1(5):643-51. Abstract
Verstovsek S et al. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): Results from an international, double-blind, randomised, controlled, phase 3 study. Lancet 2023;401(10373):269-80. Abstract
Verstovsek S et al. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Oncol 2017;10(1):156. Abstract
Verstovsek S et al. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: Results of a median 3-year follow-up of COMFORT-I. Haematologica 2015;100(4):479-88. Abstract
Verstovsek S et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012;366(9):799-807. Abstract
Module 15: Immunotherapy and Other Nontargeted Approaches for NSCLC
Dr Govindan
Awad M et al. Clinical outcomes with perioperative nivolumab (NIVO) in patients (PTS) with resectable NSCLC from the phase III CheckMate 77T study. ELCC 2024;Abstract LBA2.
Besse B et al. Adjuvant pembrolizumab versus placebo for early-stage NSCLC after resection and optional chemotherapy: Updated results from PEARLS/KEYNOTE-091. ESMO Immuno-Oncology Congress 2023;Abstract 120MO.
Bradley JD et al. Durvalumab in combination with chemoradiotherapy for patients with unresectable stage III NSCLC: Final results from PACIFIC-2. ELCC 2024;Abstract LBA1.
Cascone T et al. Neocoast-2: Efficacy and safety of neoadjuvant durvalumab (D) + novel anticancer agents + CT and adjuvant D ± novel agents in resectable NSCLC. WCLC 2024;Abstract PL02.07.
Cascone T et al. Perioperative nivolumab in resectable lung cancer. N Engl J Med 2024;390(19):1756-69. Abstract
Forde PM et al. Adjuvant nivolumab plus chemotherapy in resectable lung cancer. N Engl J Med 2022;386(21):1973-85. Abstract
Heymach JV et al. Perioperative durvalumab for resectable NSCLC (R-NSCLC): Updated outcomes from the phase 3 AEGEAN trial. WCLC 2024;Abstract OA13.03.
O’Brien MER et al. EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study of pembrolizumab versus placebo for completely resected early-stage non-small cell lung cancer (NSCLC): Outcomes in subgroups related to surgery, disease burden, and adjuvant chemotherapy use. ASCO 2022;Abstract 8512.
O’Brien MER et al. Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB-IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): An interim analysis of a randomised, triple-blind, phase 3 trial. Lancet Oncol 2022;23(10):1274-86. Abstract
Paz-Ares L et al. Pembrolizumab (pembro) versus placebo for early-stage non-small cell lung cancer (NSCLC) following complete resection and adjuvant chemotherapy (chemo) when indicated: Randomized, triple-blind, phase III EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study. ESMO Virtual Plenary 2022;Abstract VP3-2022.
Spicer J et al. Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in patients (pts) with resectable NSCLC: 4-year update from CheckMate 816. ASCO 2024;Abstract LBA8010.
Spicer JD et al. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): A randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2024;404(10459):1240-52. Abstract
Spigel DR et al. Five-year survival outcomes from the PACIFIC trial: Durvalumab after chemoradiotherapy in stage III non-small-cell lung cancer. J Clin Oncol 2022;40(12):1301-11. Abstract
Wakelee H et al. IMpower010: ctDNA status and 5y DFS follow up in patients (pts) with resected NSCLC who received adjuvant chemotherapy (chemo) followed by atezolizumab (atezo) or best supportive care (BSC). ESMO 2024;Abstract 1211P.
Wakelee H et al. Perioperative pembrolizumab for early-stage non-small-cell lung cancer. N Engl J Med 2023;389(6):491-503. Abstract
Wakelee HA et al. IMpower010: Final disease-free survival (DFS) and second overall survival (OS) interim results after ≥5 years of follow up of a phase III study of adjuvant atezolizumab vs best supportive care in resected stage IB-IIIA non-small cell lung cancer (NSCLC). ASCO 2024;Abstract LBA8035.
Wakelee HA et al. KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early stage NSCLC. ASCO 2023;Abstract LBA100.
Dr Liu
Aguilar EJ et al. Outcomes to first-line pembrolizumab in patients with non-small-cell lung cancer and very high PD-L1 expression. Ann Oncol 2019;30(10):1653-9. Abstract
Ahn M-J et al. Datopotamab deruxtecan versus docetaxel for previously treated advanced or metastatic non-small cell lung cancer: The randomized, open-label phase III TROPION-Lung01 study. J Clin Oncol 2025;43(3):260-72. Abstract
Borghaei H et al. SAPPHIRE: Phase III study of sitravatinib plus nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. Ann Oncol 2024;35(1):66-76. Abstract
Camidge DR et al. Telisotuzumab vedotin monotherapy in patients with previously treated c-Met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial. J Clin Oncol 2024;42(25):3000-11. Abstract
Garassino MC et al. Normalized membrane ratio of TROP2 by quantitative continuous scoring is predictive of clinical outcomes in TROPION-Lung 01. WCLC 2024;Abstract PL02.11.
Goto Y et al. TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) in advanced non-small cell lung cancer (aNSCLC). ASCO 2023;Abstract 9004.
Leal T et al. TTFields and immune-checkpoint inhibitor in metastatic non-small cell lung cancer: PD-L1 subgroups in the phase 3 LUNAR study. WCLC 2023;Abstract OA22.05.
Leal T et al. Tumor treating fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): A randomised, open-label, pivotal phase 3 study. Lancet Oncol 2023;24(9):1002-17. Abstract
Mehta MP et al. Results from METIS (EF-25), an international, multicenter phase III randomized study evaluating the efficacy and safety of tumor treating fields (TTFields) therapy in NSCLC patients with brain metastases. ASCO 2024;Abstract 2008.
Neal J et al. CONTACT-01: A randomized phase III trial of atezolizumab + cabozantinib versus docetaxel for metastatic non–small cell lung cancer after a checkpoint inhibitor and chemotherapy. J Clin Oncol 2024;42(20):2393-403. Abstract
Papadopoulos KP et al. Datopotamab deruxtecan (Dato-DXd) + durvalumab ± carboplatin in advanced/mNSCLC: Initial results from phase 1b TROPION-Lung04. WCLC 2023;Abstract OA05.06.
Peters S et al. Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in first-line metastatic (m) NSCLC: 5-year overall survival (OS) update from the POSEIDON study. ESMO Immuno-Oncology Congress 2023;Abstract LBA3.
Planchard D et al. Trastuzumab deruxtecan monotherapy in pretreated HER2-overexpressing nonsquamous non-small cell lung cancer: DESTINY-Lung03 part 1. WCLC 2024;Abstract OA16.05.
Reck M et al. Five-year outcomes with pembrolizumab versus chemotherapy for metastatic non-small-cell lung cancer with PD-L1 tumor proportion score ≥ 50. J Clin Oncol 2021;39(21):2339-49. Abstract
Reckamp KL et al. Phase II randomized study of ramucirumab and pembrolizumab versus standard of care in advanced non-small-cell lung cancer previously treated with Immunotherapy-Lung-MAP S1800A. J Clin Oncol 2022;40(21):2295-306. Abstract
Ricciuti B et al. Diminished efficacy of programmed death-(ligand)1 inhibition in STK11- and KEAP1-mutant lung adenocarcinoma is affected by KRAS mutation status. J Thorac Oncol 2022;17(3):399-410. Abstract
Skoulidis F et al. Krascendo-170 Lung: A phase Ib/II study of divarasib + pembrolizumab ± platinum-based chemotherapy and pemetrexed in untreated KRAS G12C+advanced non-small cell lung cancer (NSCLC). ASCO 2024;Abstract TPS8651.
Yang JC-H et al. Pembrolizumab with or without lenvatinib for first-line metastatic NSCLC with programmed cell death-ligand 1 tumor proportion score of at least 1% (LEAP-007): A randomized, double-blind, phase 3 trial. J Thorac Oncol 2024;19(6):941-53. Abstract
Zhou C et al. Phase 3 study of ivonescimab (AK112) vs. pembrolizumab as first-line treatment for PD-L1-positive advanced NSCLC: Primary analysis of HARMONi-2. WCLC 2024;Abstract PL02.04.
Module 16: Pancreatic Cancer
Dr Oberstein
Abdelrahim M et al. Impact of UGT1A1*28 polymorphism on tolerability in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX in NAPOLI 3. Gastrointestinal Cancers Symposium 2025;Abstract 717.
Conroy T et al. FOLFIRINOX or gemcitabine as adjuvant therapy for pancreatic cancer. N Engl J Med 2018;379(25):2395-406. Abstract
Conroy T et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011;364(19):1817-25. Abstract
Hussein MA et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3. Gastrointestinal Cancers Symposium 2024;Abstract 4136.
Nichetti F et al. NALIRIFOX, FOLFIRINOX, and gemcitabine with nab-paclitaxel as first-line chemotherapy for metastatic pancreatic cancer: A systematic review and meta-analysis. JAMA Netw Open 2024;7(1):e2350756. Abstract
O’Reilly EM et al. Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3 trial. ASCO 2023;Abstract 4006.
Patel AJ et al. Effect of dose adjustments on overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX: A post hoc analysis of NAPOLI 3. Gastrointestinal Cancers Symposium 2025;Abstract 716.
Siegel RL et al. Cancer statistics, 2025. CA Cancer J Clin 2025;75(1):10-45. Abstract
Sohal DPS et al. Efficacy of perioperative chemotherapy for resectable pancreatic adenocarcinoma: A phase 2 randomized clinical trial. JAMA Oncol 2021;7(3):421-7. Abstract
Von Hoff DD et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013;369(18):1691-703. Abstract
Wainberg ZA et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): A randomised, open-label, phase 3 trial. Lancet 2023;402(10409):1272-81. Abstract
Wainberg ZA et al. NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Gastrointestinal Cancers Symposium 2023;Abstract LBA661.
Wang-Gillam A et al. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer 2019:108:78-87. Abstract
Dr Philip
Conroy M et al. Emerging RAS-directed therapies for cancer. Cancer Drug Resist 2021;4(3):543–58. Abstract
Fan N et al. Methylthioadenosine phosphorylase deficiency in tumors: A compelling therapeutic target. Front Cell Dev Biol 2023;11:1173356. Abstract
Gourley C et al. Moving from poly (ADP-Ribose) polymerase inhibition to targeting DNA repair and DNA damage response in cancer therapy. J Clin Oncol 2019;37(25):2257-69. Abstract
Hammel P et al. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol 2019;30(12):1959-68. Abstract
Kim TM et al. Matching-adjusted indirect comparison of amivantamab vs mobocertinib in platinum-pretreated EGFR exon 20 insertion-mutated non-small-cell lung cancer. Future Oncol 2024;20(8):447-58. Abstract
Kindler HL et al. Overall survival results from the POLO trial: A phase III study of active maintenance olaparib versus placebo for germline BRCA-mutated metastatic pancreatic cancer. J Clin Oncol 2022;40(34):3929-39. Abstract
Philip PA et al. Molecular characterization of KRAS wild-type tumors in patients with pancreatic adenocarcinoma. Clin Cancer Res 2022;28(12):2704-14. Abstract
Rivera F et al. Tumor treating fields in combination with gemcitabine or gemcitabine plus nab-paclitaxel in pancreatic cancer: Results of the PANOVA phase 2 study. Pancreatology 2019;19(1):64-72. Abstract
Rojas LA et al. Personalized RNA neoantigen vaccines stimulate T cells in pancreatic cancer. Nature 2023;618(7963):144-50. Abstract
Schram AM et al. Efficacy of zenocutuzumab in NRG1 fusion-positive cancer. N Engl J Med 2025;392(6):566-76. Abstract
Waters AM, Der CJ. KRAS: The critical driver and therapeutic target for pancreatic cancer. Cold Spring Harb Perspect Med 2018;8(9):a031435. Abstract
Module 17: Gastroesophageal Cancer
Dr Janjigian
Al-Batran SE et al. Pembrolizumab plus FLOT vs FLOT as neoadjuvant and adjuvant therapy in locally advanced gastric and gastroesophageal junction cancer: Interim analysis of the phase 3 KEYNOTE-585 study. ASCO 2024;Abstract 247.
Hoeppner J et al. Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial). ASCO 2024;Abstract LBA1.
Janjigian YY et al. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up results from CheckMate 649. Gastrointestinal Cancers Symposium 2025;Abstract 398.
Janjigian YY et al. Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma. ESMO 2024;Abstract 1400O.
Janjigian YY et al. Pathological complete response (pCR) to 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) with or without durvalumab (D) in resectable gastric and gastroesophageal junction cancer (GC/GEJC): Subgroup analysis by region from the phase 3, randomized, double-blind MATTERHORN study. Gastrointestinal Cancers Symposium 2024;Abstract LBA246.
Janjigian YY et al. Pembrolizumab in HER2-positive gastric cancer. N Engl J Med 2024;391(14):1360-2. Abstract
Janjigian YY et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): A randomised, open-label, phase 3 trial. Lancet 2021;398(10294):27-40. Abstract
Kelly RJ et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N Engl J Med 2021;384(13):1191-203. Abstract
Kelly RJ et al. Adjuvant nivolumab (NIVO) in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiotherapy (CRT): Expanded efficacy and safety analyses from CheckMate 577. ASCO 2021;Abstract 4003.
Leong T et al. Preoperative chemoradiotherapy for resectable gastric cancer. N Engl J Med 2024;391(19):1810-21. Abstract
Qiu MZ et al. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ 2024;385. Abstract
Shitara K et al. Final analysis of the phase III KEYNOTE-585 study of pembrolizumab plus chemotherapy vs chemotherapy as perioperative therapy in locally-advanced gastric and gastroesophageal junction cancer. ESMO Gastrointestinal Cancers Congress 2024;Abstract LBA3.
Dr Klempner
Janjigian YY et al. Updated results from the trastuzumab deruxtecan (T-DXd) 5.4 mg/kg triplet combination of DESTINY-Gastric03 (DG-03): First-line (1L) T-DXd with fluoropyrimidine (FP) and pembrolizumab in advanced/metastatic HER2-positive (HER2+) esophageal adenocarcinoma, gastric cancer (GC), or gastroesophageal junction adenocarcinoma (GEJA). Gastrointestinal Cancers Symposium 2025;Abstract 448.
Janjigian YY et al. First-line nivolumab plus chemotherapy for advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma: 3-year follow-up of the phase III CheckMate 649 trial. J Clin Oncol 2024;42(17):2012-20. Abstract
Janjigian YY et al. Phase 1b/2, open-label dose-escalation and -expansion study evaluating trastuzumab deruxtecan (T-DXd) monotherapy and combinations in patients (pts) with HER2+ and HER2-low gastric cancer (GC): DESTINY-Gastric03 (DG-03). Gastrointestinal Cancers Symposium 2024;Abstract TPS424.
Kim T-Y et al. Clinicopathological analysis of claudin 18.2 focusing on intratumoral heterogeneity and survival in patients with metastatic or unresectable gastric cancer. ESMO Open 2024;9(12):104000. Abstract
Liu JJ et al. Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase I study. ESMO Gastrointestinal Cancers Congress 2024;Abstract 396MO.
Nakayama I et al. Claudin 18.2 as a novel therapeutic target. Nat Rev Clin Oncol 2024;21(5):354-69. Abstract
Qi C et al. Claudin18.2-specific CAR T cells in gastrointestinal cancers: Phase 1 trial final results. Nat Med 2024;30(8):2224-34. Abstract
Rha SY et al. Prevalence of FGFR2b protein overexpression in advanced gastric cancers during prescreening for the phase III FORTITUDE-101 trial.JCO Precis Oncol 2025;9. Abstract
Ruan DY et al. Claudin 18.2-targeting antibody-drug conjugate CMG901 in patients with advanced gastric or gastro-oesophageal junction cancer (KYM901): A multicentre, open-label, single-arm, phase 1 trial. Lancet Oncol 2025;26(2):227-38. Abstract
Shitara K et al. Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC). Gastrointestinal Cancers Symposium 2025;Abstract 332.
Shitara K et al. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.Gastric Cancer 2024;27(5):1058-68. Abstract
Shitara K et al. Zolbetuximab in gastric or gastroesophageal junction adenocarcinoma. N Engl J Med 2024;391(12):1159-62. Abstract
Shitara K et al. Zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) withclaudin-18.2+ (CLDN18.2+) / HER2− locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary results from phase 3 SPOTLIGHT study. Gastrointestinal Cancers Symposium 2023;Abstract LBA292.
Shitara K et al. Trastuzumab deruxtecan (T-DXd) in patients (Pts) with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen (DESTINY-gastric04, DG-04): A randomized phase III study. ESMO 2021;Abstract 1436TiP.
Shitara K et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Engl J Med 2020;382(25):2419-30. Abstract
Van Cutsem E et al. Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): Primary and updated analyses from a single-arm, phase 2 study. Lancet Oncol 2023;24(7):744-56. Abstract
Wainberg ZA et al. Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): A randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol 2022;23(11):1430-40. Abstract
Xu R et al. CLDN18.2 targeted antibody-drug conjugate (ADC), SHR-A1904, in patients (pts) with gastric/gastroesophageal junction cancer (GC/GEJC): A phase I study. ESMO 2024;Abstract 609O.