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LIVE WEBINAR: Saturday, May 15, 2021, 7:30 AM – 3:30 PM Pacific Time (10:30 AM – 6:30 PM Eastern Time)

Current Concepts and Recent Advances in Oncology: A Daylong Clinical Summit Hosted in Partnership with Medical Oncology Association of Southern California (MOASC)

A CME-MOC/NCPD Accredited Virtual Event

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Event Details

Join us on Saturday, May 15 for this daylong multitumor CME-MOC/NCPD-accredited live webinar
7:30 AM – 3:30 PM Pacific Time (10:30 AM – 6:30 PM Eastern Time)

Faculty

Breast Cancer

Ruth O’Regan, MD
Chair, Department of Medicine
Charles A Dewey Professor of Medicine
University of Rochester
Rochester, New York

Tiffany A Traina, MD
Vice Chair, Oncology Care
Section Head, Triple-Negative Breast Cancer Clinical Research Program
Associate Attending Physician
Breast Medicine Service
Department of Medicine
Memorial Sloan Kettering Cancer Center
Associate Professor
Weill Cornell Medical College
New York, New York

Lung Cancer

D Ross Camidge, MD, PhD
Professor of Medicine/Oncology
Joyce Zeff Chair in Lung Cancer Research
Director of Thoracic Oncology
University of Colorado, Anschutz Medical Campus
Denver, Colorado

Benjamin Levy, MD
Associate Professor
Johns Hopkins School of Medicine
Clinical Director
Medical Director, Thoracic Oncology Program
Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial
Washington, DC

Gastrointestinal Cancers

Wells A Messersmith, MD
Professor and Head, Division of Medical Oncology
Associate Director for Translational Research
University of Colorado Cancer Center
Aurora, Colorado

Eileen M O’Reilly, MD
Winthrop Rockefeller Endowed Chair in Medical Oncology
Section Head, Hepatopancreaticobiliary and Neuroendocrine Cancers
Co-Director, Medical Initiatives
David M Rubenstein Center for Pancreatic Cancer Research
Attending Physician, Member
Memorial Sloan Kettering Cancer Center
Professor of Medicine, Weill Cornell Medical College
New York, New York

Genitourinary Cancers

Joaquim Bellmunt, MD, PhD
Director, Bladder Cancer Program
Beth Israel Deaconess Medical Center
Associate Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Sumanta Kumar Pal, MD
Clinical Professor, Department of Medical Oncology and Therapeutics Research
City of Hope Comprehensive Cancer Center
Duarte, California

Multiple Myeloma

Kenneth Anderson, MD
Director, Jerome Lipper Multiple Myeloma Center
Dana-Farber Cancer Institute
Kraft Family Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Noopur Raje, MD
Director, Center for Multiple Myeloma
Massachusetts General Hospital Cancer Center
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

Acute Myeloid Leukemia and Myelodysplastic Syndromes

Harry Paul Erba, MD, PhD
Director, Leukemia Program
Instructor in the Department of Medicine
Member of the Duke Cancer Institute
Duke University School of Medicine
Durham, North Carolina

Rami Komrokji, MD
Senior Member and Section Head for Leukemia and MDS
Vice Chair, Department of Malignant Hematology
Moffitt Cancer Center
Professor of Oncologic Sciences
Morsani College of Medicine, University of South Florida
Tampa, Florida

Chronic Lymphocytic Leukemia and Lymphomas

Craig Moskowitz, MD
Physician in Chief, Oncology Service Line
Sylvester Comprehensive Cancer Center
Professor of Medicine, Miller School of Medicine
University of Miami Health System
Miami, Florida

Jeff Sharman, MD
Medical Director of Hematology Research
US Oncology Network
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


This activity is supported by educational grants from AbbVie Inc, Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Daiichi Sankyo Inc, Epizyme Inc, Exact Sciences, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Lilly, Merck, Novartis, Oncopeptides, Sanofi Genzyme, Seagen Inc and Taiho Oncology Inc.

Agenda

CME-MOC/NCPD-accredited LIVE Webinar
Saturday, May 15, 2021
7:30 AM – 3:30 PM Pacific Time (10:30 AM – 6:30 PM Eastern Time)

Final schedule to be provided

Breast Cancer | 10:30 AM – 11:30 AM ET (7:30 AM – 8:30 AM PT)

Case presentations and topics to be discussed

A patient with localized HER2-positive breast cancer (BC)

  • Key clinical factors affecting the decision to administer neoadjuvant treatment for patients with HER2-positive localized BC
  • Clinical implications of the FDA approval of adjuvant T-DM1 for patients with residual disease after neoadjuvant therapy
  • Available efficacy and safety results from the Phase II ATEMPT study comparing adjuvant T-DM1 to paclitaxel/trastuzumab for Stage I HER2-positive BC; current role, if any, in clinical practice
  • Long-term efficacy and safety findings with pertuzumab as a component of adjuvant treatment for HER2-positive localized BC
  • Current role of neratinib as extended-adjuvant therapy; patient selection and clinical factors guiding its use in practice
  • FDA approval of a fixed-dose subcutaneous formulation of pertuzumab, trastuzumab and hyaluronidase-zzxf; optimal integration into current clinical management
  • Ongoing and planned clinical trials investigating novel HER2-targeted strategies (eg, CompassHER2 RD, DESTINY-Breast05) for HER2-positive localized BC; estimated study completion dates

A patient with high-risk ER-positive, HER2-negative localized BC

  • Factors affecting the decision to consult a genomic assay in the adjuvant setting for patients with ER-positive localized BC
  • Emerging findings from the Phase III RxPONDER study evaluating the 21-gene Recurrence Score® for patients with ER-positive early BC and 1 to 3 positive nodes
  • Available and emerging data with and current clinical role, if any, of genomic assays to guide decision-making in the preoperative setting
  • Biologic rationale for the evaluation of CDK4/6 inhibitors for ER-positive, HER2-negative localized BC
  • Improvement in invasive disease-free survival observed with the addition of abemaciclib to standard adjuvant hormonal therapy for patients with ER-positive, HER2-negative BC at high risk for recurrence in the Phase III monarchE trial
  • Spectrum, frequency and severity of toxicities reported with abemaciclib in monarchE; rates of treatment discontinuation before 2 years
  • Clinical and research implications of monarchE and potential role of adjuvant abemaciclib
  • Key efficacy and safety findings from the Phase III PALLAS and PENELOPE-B trials evaluating palbociclib in combination with standard adjuvant endocrine therapy for patients with ER-positive localized BC
  • Other ongoing and planned clinical research studies evaluating CDK4/6 inhibitors as neoadjuvant or adjuvant therapy (eg, NATALEE, POETIC-A)

A patient with localized triple-negative BC (TNBC)

  • Available results from the Phase III KEYNOTE-522 trial documenting the benefit of neoadjuvant pembrolizumab with chemotherapy compared to chemotherapy alone for TNBC
  • Key efficacy and safety findings from the Phase III IMpassion031 study evaluating atezolizumab in combination with chemotherapy as neoadjuvant treatment for patients with early TNBC
  • Current nonresearch role, if any, of neoadjuvant checkpoint inhibition for patients with TNBC
  • Ongoing randomized Phase III clinical trials evaluating the use of anti-PD-1/PD-L1 antibodies in combination with chemotherapy for localized TNBC (eg, IMpassion030, SWOG-S1418)

A patient with HER2-positive metastatic BC (mBC)

  • Clinical factors (eg, prior HER2-directed therapy, symptomatology, disease-free interval, sites of metastases) affecting the selection of therapy for patients with HER2-positive mBC
  • Available efficacy and safety data from the pivotal Phase II HER2CLIMB trial of tucatinib in combination with trastuzumab/capecitabine for HER2-positive mBC
  • Outcomes from the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan for previously treated HER2-positive advanced BC
  • Key findings from the Phase III NALA study of neratinib/capecitabine versus lapatinib/capecitabine for HER2-positive mBC
  • Recent FDA approvals of tucatinib/trastuzumab/capecitabine, trastuzumab deruxtecan, neratinib/capecitabine and margetuximab/chemotherapy; optional integration into therapy for patients with and without brain metastases
  • Comparative adverse event profiles of the newer anti-HER2 therapies; strategies to monitor for, prevent and manage complications

A patient with ER-positive, HER2-negative mBC

  • Long-term follow-up data and factors affecting the selection of a CDK4/6 inhibitor and an endocrine partner for patients with ER-positive mBC
  • Incidence, monitoring and management of common class- and agent-specific toxicities associated with CDK4/6 inhibition
  • Published research findings leading to the FDA approval of alpelisib/fulvestrant for ER-positive mBC with a PIK3CA mutation; Phase II BYLieve study affirming the utility of this combination after disease progression on a CDK4/6 inhibitor
  • Spectrum, frequency and severity of alpelisib-related toxicities; optimal prevention and management strategies (eg, prophylactic antihistamines)
  • Other novel agents and strategies under investigation for ER-positive mBC (eg, patritumab deruxtecan, AKT inhibitors)

A patient with metastatic TNBC

  • Current indications for testing PD-L1 expression in patients with metastatic TNBC; optimal testing platforms
  • Long-term efficacy and safety findings from the Phase III IMpassion130 trial evaluating atezolizumab/nab paclitaxel as first-line therapy for metastatic TNBC
  • Primary results from the Phase III IMpassion131 study of first-line paclitaxel with or without atezolizumab for metastatic TNBC; recent FDA alert regarding efficacy and safety concerns with this combination
  • Recent FDA approval of pembrolizumab combined with chemotherapy for previously untreated metastatic TNBC and key findings from the pivotal KEYNOTE-355 trial; effect of chemotherapy partner on outcomes
  • FDA approvals of atezolizumab/nab paclitaxel and pembrolizumab/chemotherapy for PD-L1-positive metastatic TNBC; optimal integration into practice
  • Incidence of BRCA1/2 alterations and other genetic abnormalities predictive of sensitivity to PARP inhibition in patients with BC; optimal integration of olaparib and talazoparib
  • Key findings from the Phase II TBCRC 048 study of olaparib monotherapy for patients with mBC with germline or somatic mutations in DNA damage response pathway genes beyond germline BRCA1/2
  • Mechanism of action, available data and FDA approval of sacituzumab govitecan
  • Other promising antibody-drug conjugates under investigation for this disease subset (eg, ladiratuzumab vedotin, datopotamab deruxtecan)

Multiple Myeloma | 11:30 AM – 12:30 PM ET (8:30 AM – 9:30 AM PT)

Case presentations and topics to be discussed

A younger, transplant-eligible patient with newly diagnosed multiple myeloma (MM)
An older, transplant-ineligible patient with newly diagnosed MM

  • Clinical and biologic factors in the selection of an optimal induction/consolidation regimen for patients with transplant-eligible or ineligible MM
  • Available efficacy and safety findings from and clinical implications of the Phase III ENDURANCE (E1A11) trial of KRd (carfilzomib/lenalidomide/dexamethasone) versus lenalidomide/bortezomib/dexamethasone (RVd) as initial therapy for newly diagnosed MM
  • Published research findings from Phase III trials evaluating daratumumab-containing front-line regimens for newly diagnosed MM; current clinical role for transplant-eligible and ineligible patients
  • Updated data from the Phase II GRIFFIN study evaluating RVd/daratumumab for transplant-eligible patients with newly diagnosed MM; recent inclusion in NCCN guidelines and potential nonresearch role
  • Correlation between minimal residual disease (MRD) negativity and long-term outcomes for patients with newly diagnosed MM undergoing active treatment; role of MRD assessment to inform decision-making in routine practice
  • Optimal approach to maintenance therapy for patients who receive front-line daratumumab-based regimens
  • Selection of an optimal maintenance approach for transplant-eligible and ineligible patients
  • Available efficacy and safety outcomes with and current indications, if any, for ixazomib as maintenance therapy

A patient who receives up-front RVd followed by transplant and lenalidomide maintenance but then experiences disease relapse
An older patient who received Rd/daratumumab and experiences disease progression
A patient with R/R MM who has experienced disease progression on multiple lines of conventional therapy

  • Clinical, biologic and practical factors in the selection, sequencing and combining of carfilzomib, pomalidomide, daratumumab, elotuzumab and ixazomib for patients with R/R MM
  • Available clinical research findings with and optimal therapeutic partner for daratumumab for R/R MM; recent FDA approval of daratumumab/carfilzomib/dexamethasone
  • Mechanism of action of isatuximab; structural and pharmacologic similarities and differences between isatuximab and daratumumab and implications, if any, for activity and tolerability
  • Published Phase III research experience with isatuximab for R/R MM (eg, ICARIA-MM, IKEMA trials); optimal use in clinical practice and ongoing research
  • Mechanism of action of selinexor and published research leading to the FDA approval for multiple regimen-refractory MM; optimal incorporation into routine practice
  • Recent FDA approval of selinexor in combination with bortezomib/dexamethasone for patients with R/R MM who have received at least 1 prior therapy, and key results from the pivotal BOSTON study
  • Structural composition and mechanism of action of the BCMA-directed antibody-drug conjugate belantamab mafodotin
  • Efficacy and safety results from the Phase II DREAMM-2 study leading to the FDA approval of belantamab mafodotin for R/R MM; incorporation into routine practice and monitoring and management of ocular and other toxicities
  • Available data from the DREAMM-6 trial investigating belantamab mafodotin in combination with bortezomib/dexamethasone; ongoing evaluation in combination with other systemic therapies

A patient with R/R MM who has experienced disease progression on multiple lines of conventional therapy and is interested in participating in a clinical research study

  • Compositional and mechanistic similarities and differences among various BCMA-targeted CAR T-cell platforms under investigation for MM
  • Design, eligibility criteria and available efficacy and safety results from the pivotal Phase II KarMMa trial evaluating idecabtagene vicleucel for R/R MM; developmental timeline and potential clinical role
  • Safety and efficacy findings from the Phase Ib/II CARTITUDE-1 study leading to the FDA breakthrough therapy designation of ciltacabtagene autoleucel for R/R disease
  • Early data with and ongoing clinical research evaluating other CAR T-cell platforms (eg, orvacabtagene autoleucel, bb21217) for MM
  • Optimal timing and selection of patients for enrollment in clinical trials assessing CAR T-cell therapy for MM
  • Incidence and severity of class-effect toxicities observed with BCMA-targeted CAR T-cell therapy
  • Biologic rationale, available data and favorable risk-benefit ratio associated with venetoclax-based therapy for patients with MM and t(11;14) or Bcl-2 overexpression; current nonresearch role in these populations
  • Anticipated completion date of the Phase III CANOVA trial evaluating venetoclax/dexamethasone versus pomalidomide/dexamethasone for patients with R/R MM positive for t(11;14); other ongoing studies assessing venetoclax-based combination therapy
  • Mechanism of action of melflufen; similarities and differences between melflufen and standard melphalan
  • Key efficacy and safety data from the Phase II HORIZON study evaluating melflufen/dexamethasone for R/R MM; FDA priority review status for triple-refractory disease and development plans
  • Other promising novel agents and strategies under investigation (eg, CELMoDs, bispecific antibodies)

SHORT PROGRAM BREAK | 12:30 PM – 12:50 PM ET (9:30 AM – 9:50 AM PT)

Chronic Lymphocytic Leukemia and Lymphomas | 12:50 PM – 1:50 PM ET (9:50 AM – 10:50 AM PT)

Case presentations and topics to be discussed

A younger patient with newly diagnosed chronic lymphocytic leukemia (CLL) with an IGHV mutation
An older patient with newly diagnosed CLL with no IGHV mutation

  • Clinical and biologic factors in the selection of a first-line treatment regimen for patients with newly diagnosed CLL
  • Phase III data sets comparing ibrutinib-based therapy to standard chemoimmunotherapy for younger (ECOG-E1912) and older (Alliance A041202, iLLUMINATE) patients with treatment-naïve CLL
  • Design, eligibility criteria and key efficacy and safety findings from the Phase III ELEVATE-TN trial leading to the FDA approval of acalabrutinib for previously untreated CLL
  • Efficacy and safety findings from the Phase III CLL14 trial evaluating venetoclax/obinutuzumab versus chlorambucil/obinutuzumab for patients with treatment-naïve CLL and coexisting medical conditions; clinical implications of the FDA approval of this regimen
  • Spectrum, frequency and severity of toxicities associated with BTK inhibitors and venetoclax-based treatment; optimal management strategies and implications for treatment selection

A patient with CLL who experiences disease progression on first-line therapy

  • Long-term outcomes with venetoclax with or without rituximab for patients with R/R CLL
  • Key efficacy and safety findings from the Phase III ASCEND trial comparing acalabrutinib to rituximab in combination with either idelalisib or bendamustine for patients with R/R CLL
  • Current clinical roles of the PI3K inhibitors idelalisib and duvelisib in the CLL treatment paradigm
  • Mechanisms of action, available data and ongoing evaluation of novel noncovalent reversible BTK inhibitors for R/R CLL; potential role in CLL management
  • Available efficacy and safety outcomes from studies evaluating novel combinations of BTK and Bcl-2 inhibitors for previously untreated and R/R CLL; ongoing Phase III studies
  • Biologic rationale for the evaluation of CD19-directed chimeric antigen receptor (CAR) T-cell therapy for patients with R/R CLL; key findings from the Phase I/II TRANSCEND CLL 004 trial assessing lisocabtagene maraleucel for R/R CLL

A patient with newly diagnosed follicular lymphoma (FL)

  • Integration of obinutuzumab into current algorithms for treatment-naïve and R/R FL; potential benefit in preventing early disease progression
  • Clinical and research implications of the Phase III RELEVANCE trial evaluating the “R-squared” (R2) regimen of lenalidomide/rituximab for newly diagnosed FL
  • Available results from Phase III trials evaluating R2 for R/R FL; recent FDA approval and patient selection
  • Current clinical role of and patient selection for PI3 kinase inhibition for FL
  • Mechanism of action, efficacy and tolerability of tazemetostat in patients with previously treated FL
  • Recent FDA approval and current clinical role of tazemetostat for patients with and without EZH2 mutations
  • Available data with CD19-directed CAR T-cell therapy (eg, tisagenlecleucel, axicabtagene ciloleucel) for R/R FL
  • FDA regenerative medicine advanced therapy designation for tisagenlecleucel and priority review status for axicabtagene ciloleucel; potential role in FL treatment
  • Mechanism of action of mosunetuzumab; available data leading to its FDA breakthrough therapy designation for R/R FL and ongoing evaluation

A patient with relapsed diffuse large B-cell lymphoma (DLBCL)

  • Available efficacy and safety data with polatuzumab vedotin in combination with bendamustine/rituximab for patients with R/R DLBCL; optimal incorporation into management algorithms
  • Long-term data with axicabtagene ciloleucel, tisagenlecleucel and lisocabtagene maraleucel for R/R DLBCL
  • Patient identification and appropriate referral for consideration of CAR T-cell therapy
  • Results from the ZUMA-12 study evaluating axicabtagene ciloleucel as first-line therapy for high-risk large B-cell lymphoma
  • Biologic rationale for the investigation of selinexor for R/R DLBCL
  • Design, eligibility criteria and key efficacy and safety findings from the Phase IIb SADAL trial evaluating selinexor for patients with R/R DLBCL who have received at least 2 prior multidrug therapies and who are ineligible for stem cell transplantation or CAR T-cell therapy; FDA approval and optimal sequencing
  • Mechanism of action of tafasitamab and biologic rationale for combining it with lenalidomide for DLBCL
  • Key efficacy and safety findings leading to the FDA approval of tafasitamab/lenalidomide for R/R DLBCL; patient selection for treatment with this regimen

A patient with relapsed mantle cell lymphoma (MCL)

  • Research database supporting the FDA approvals of ibrutinib, acalabrutinib and zanubrutinib for R/R MCL; patient selection for routine use
  • Activity and safety data with and ongoing Phase III investigations of BTK inhibitors for previously untreated MCL
  • Available data with, current clinical role of and ongoing trials assessing venetoclax alone or combined with other agents for MCL
  • Design, eligibility criteria and available safety and efficacy findings from studies evaluating CAR T-cell therapy for R/R MCL
  • FDA approval of brexucabtagene autoleucel and optimal integration into current MCL treatment algorithms
  • Design, eligibility criteria and key efficacy and safety findings from the BRUIN trial evaluating the noncovalent BTK inhibitor LOXO-305 for B-cell neoplasms, including MCL

A patient with newly diagnosed Hodgkin lymphoma (HL)

  • Role of brentuximab vedotin (BV) in combination with AVD (doxorubicin/vinblastine/dacarbazine) as first-line therapy for advanced classical HL
  • Available data with and current role of BV for elderly patients with newly diagnosed HL
  • Potential role of BV alone or in combination with immune checkpoint inhibition as a bridge to transplant in patients experiencing disease progression on up-front treatment
  • Results from the Phase III KEYNOTE-204 trial evaluating pembrolizumab versus BV for patients with R/R HL; implications for clinical practice
  • Available activity and safety data with and ongoing evaluation of anti-PD-1/PD-L1 antibodies alone or in combination with other systemic approaches (eg, BV, chemotherapy) for patients with HL

Genitourinary Cancers | 1:50 PM – 2:50 PM ET (10:50 AM – 11:50 AM PT)

Case presentations and topics to be discussed

A patient with nonmetastatic prostate cancer (PC) and rising PSA on androgen deprivation therapy (ADT)

  • Rates of castration resistance-free survival and major cardiovascular events with the oral GnRH antagonist relugolix compared to leuprolide for advanced PC in the Phase III HERO study; potential clinical role of relugolix
  • Design, eligibility criteria and key primary and secondary endpoints evaluated in the Phase III PROSPER, SPARTAN and ARAMIS trials assessing enzalutamide, apalutamide and darolutamide, respectively, for patients with nonmetastatic castration-resistant PC (CRPC)
  • Key efficacy outcomes observed in PROSPER, SPARTAN and ARAMIS; metastasis-free survival and overall survival benefits with the addition of the antiandrogen agent
  • FDA approvals of enzalutamide, apalutamide and darolutamide for nonmetastatic CRPC; patient selection and practical integration based on patient- and disease-specific factors
  • Spectrum, frequency and severity of toxicities associated with enzalutamide, apalutamide and darolutamide in the PROSPER, SPARTAN and ARAMIS trials; implications for selection of therapy

A patient with newly diagnosed metastatic PC who has received no prior systemic therapy

  • Recent FDA approval of the PSMA-targeted PET imaging drug Gallium 68 PSMA-11; current role in the detection of PC metastases
  • Key clinical and practical factors guiding the selection of docetaxel, abiraterone, enzalutamide or apalutamide in combination with ADT for patients with metastatic hormone-sensitive PC (HSPC)
  • Available efficacy and safety findings with chemotherapy and secondary hormonal agents in combination with ADT for men with metastatic HSPC (mHSPC)
  • Design, entry criteria and primary and secondary endpoints of the Phase III ARCHES and TITAN trials comparing enzalutamide or apalutamide in combination with ADT to ADT alone for mHSPC; key efficacy and safety outcomes
  • Results from the Phase III ENZAMET study of enzalutamide with ADT versus other nonsteroidal antiandrogens (eg, bicalutamide, nilutamide or flutamide) with ADT for patients with mHSPC
  • FDA approval of enzalutamide and apalutamide for mHSPC and optimal integration into clinical practice
  • Design, eligibility criteria, stratification factors and key endpoints of the Phase III ARASENS trial assessing darolutamide in combination with docetaxel for men with mHSPC

A patient with metastatic CRPC (mCRPC)

  • Key considerations in the selection and sequencing of therapy for patients with mCRPC; impact of earlier use of chemotherapy and secondary hormonal therapy
  • Major efficacy and safety findings from the CARD trial comparing cabazitaxel to an androgen receptor (AR)-targeted agent for patients with mCRPC progressing after docetaxel and an alternative AR-targeted agent; implications for sequencing therapy
  • Clinical trial data with PARP inhibitors (eg, olaparib, rucaparib, niraparib, talazoparib) for patients with progressive mCRPC
  • Recent FDA approvals of rucaparib and olaparib for mCRPC; indications for genetic testing and the use of PARP inhibitors in clinical practice
  • Frequency of PTEN loss in mCRPC; key efficacy and safety data from the Phase III IPATential150 trial demonstrating improved radiographic progression-free survival with ipatasertib in combination with abiraterone/prednisone in this population
  • Preliminary findings from the mCRPC cohort of the Phase Ib COSMIC-021 trial evaluating cabozantinib in combination with atezolizumab; design and key endpoints of the Phase III CONTACT-02 trial

A patient with newly diagnosed advanced renal cell carcinoma (RCC)

  • Key considerations in the selection of nivolumab/ipilimumab, tyrosine kinase inhibitor (TKI) with anti-PD-1/PD-L1 combinations and TKI monotherapy for patients with newly diagnosed RCC
  • Major efficacy and safety findings with nivolumab/ipilimumab for treatment-naïve advanced RCC
  • Available data from the Phase III KEYNOTE-426 and JAVELIN Renal 101 trials assessing pembrolizumab/axitinib and avelumab/axitinib, respectively, in the front-line setting
  • Recent FDA approval of nivolumab in combination with cabozantinib for previously untreated advanced RCC and key results from the pivotal CheckMate 9ER study; optimal incorporation into clinical practice
  • Emerging findings and clinical implications of the Phase III KEYNOTE-581/CLEAR trial evaluating lenvatinib in combination with either pembrolizumab or everolimus versus sunitinib as first-line treatment for advanced RCC

A patient with advanced RCC who experiences disease progression on first-line checkpoint inhibitor-based therapy

  • Clinical and biologic factors in the selection of therapy for patients experiencing relapse on first-line treatment
  • Published research database with cabozantinib for R/R RCC; current role for patients experiencing disease progression on checkpoint inhibitor-based therapies
  • Role of rechallenge with alternative checkpoint inhibitor-based approaches for patients whose disease has previously progressed on immunotherapy
  • Published research data with and optimal clinical application of lenvatinib for progressive RCC
  • Mechanism of action of tivozanib; design, entry criteria and major clinical outcomes from the Phase III TIVO-3 trial comparing tivozanib to sorafenib as third- or fourth-line therapy for RCC
  • Available clinical trial data with and ongoing evaluation of other novel agents/strategies in treatment-naïve and R/R metastatic RCC

A patient with high-risk nonmetastatic urothelial bladder cancer (UBC)

  • Efficacy and safety findings from the KEYNOTE-057 trial supporting the FDA approval of pembrolizumab monotherapy for high-risk non-muscle-invasive UBC unresponsive or refractory to BCG therapy; selection of patients for pembrolizumab therapy
  • Rates of pathologic complete response and other clinically relevant outcomes with neoadjuvant pembrolizumab and atezolizumab for patients with resectable muscle-invasive UBC in the Phase II PURE-01 and ABACUS trials, respectively
  • Design, eligibility criteria and key efficacy and safety endpoints evaluated in the Phase III CheckMate 274 trial comparing nivolumab to placebo after surgery for patients with high-risk muscle-invasive UBC
  • Disease-free survival advantage with nivolumab in CheckMate 274; potential role in clinical practice

A patient with newly diagnosed metastatic UBC (mUBC)

  • Defining platinum eligibility in patients with newly diagnosed mUBC; current role of single-agent anti-PD-1/PD-L1 antibodies as first-line therapy for patients not eligible for chemotherapy
  • Key efficacy and safety results from the Phase III JAVELIN Bladder 100 trial evaluating first-line maintenance therapy with avelumab; recent FDA approval and current clinical role
  • Clinical implications of the Phase III IMvigor130 and KEYNOTE-361 trials evaluating the addition of atezolizumab and pembrolizumab, respectively, to platinum-based chemotherapy for previously untreated mUBC; current role, if any, of front-line chemoimmunotherapy
  • Published efficacy findings with and FDA breakthrough therapy designation for enfortumab vedotin in combination with pembrolizumab for locally advanced or metastatic UBC
  • Biologic rationale for and available data with anti-PD-1/PD-L1 antibodies combined with anti-CTLA-4 antibodies for mUBC
  • Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies

A patient with mUBC who has experienced disease progression on checkpoint inhibitor-based therapy

  • Spectrum and frequency of FGFR alterations in patients with mUBC; indications for molecular assessment
  • Efficacy and safety data supporting the FDA approval of erdafitinib for patients with locally advanced or metastatic UBC with susceptible FGFR3 or FGFR2 genetic alterations who have experienced disease progression on or after chemotherapy
  • Published efficacy and safety findings from the pivotal Phase II EV-201 trial evaluating enfortumab vedotin for locally advanced or metastatic UBC
  • EV-201 results and the FDA approval of enfortumab vedotin for progressive UBC; optimal integration into management algorithms
  • Available data with and current clinical role of enfortumab vedotin for patients who have previously received an anti-PD-1/PD-L1 antibody and have not received platinum-containing chemotherapy and are ineligible for cisplatin
  • Incidence and severity of adverse events with enfortumab vedotin and erdafitinib; optimal monitoring and management strategies
  • Published research findings and ongoing evaluation of other promising agents and strategies for UBC (eg, futibatinib, infigratinib, sacituzumab govitecan, cabozantinib)

PROGRAM BREAK | 2:50 PM – 3:15 PM ET (11:50 AM – 12:15 PM PT)

Gastrointestinal Cancers | 3:15 PM – 4:15 PM ET (12:15 PM – 1:15 PM PT)

Case presentations and topics to be discussed

A patient with newly diagnosed metastatic colorectal cancer (mCRC)

  • Indications for molecular testing in patients with mCRC
  • Available data linking tumor sidedness to response to specific therapeutic interventions for mCRC
  • Published research findings from the Phase III BEACON CRC trial comparing encorafenib/cetuximab with or without binimetinib to irinotecan/cetuximab or FOLFIRI/cetuximab for mCRC with a BRAF V600E mutation
  • FDA approval of encorafenib/cetuximab for patients with mCRC with BRAF mutations; appropriate integration into practice
  • Available results from the Phase II DESTINY-CRC01 study of trastuzumab deruxtecan for patients with HER2-expressing mCRC; potential nonresearch role
  • Rational incorporation of regorafenib and TAS-102 into treatment algorithms for multiple regimen-relapsed mCRC
  • Available data with and potential role of TAS-102 in combination with other systemic agents for mCRC and in earlier disease stages

A patient with microsatellite instability-high (MSI-H) mCRC

  • Key efficacy and safety results from the Phase III KEYNOTE-177 study of front-line pembrolizumab versus chemotherapy for MSI-H/mismatch repair-deficient (dMMR) mCRC
  • Rational incorporation of pembrolizumab, nivolumab and nivolumab/ipilimumab into the treatment of MSI-H/dMMR mCRC
  • Early responses observed with anti-PD-1/PD-L1 antibody-based therapies in patients with microsatellite-stable (MSS) mCRC
  • Ongoing investigation of immune checkpoint inhibitors in combination with other systemic approaches (eg, chemotherapy, targeted therapy) for MSI-H/dMMR and for MSS mCRC

A patient with newly diagnosed metastatic gastric cancer

  • Current approach to the management of newly diagnosed metastatic gastric/gastroesophageal junction (GEJ) cancer; rationale for and timing of PD-L1 testing and other biomarker analyses
  • Available efficacy and safety results from recent studies (CheckMate 649, ATTRACTION-4) comparing first-line nivolumab/chemotherapy to chemotherapy alone for advanced gastric/GEJ adenocarcinoma; clinical implications
  • Outcomes observed with first-line pembrolizumab with and without chemotherapy in the Phase III KEYNOTE-062 trial; ramifications, if any, for clinical care

A patient with HER2-positive metastatic gastric cancer who experiences disease progression on first-line FOLFOX/trastuzumab

  • Current management of (R/R) HER2-positive gastric/GEJ cancer
  • Integration of ramucirumab into current clinical algorithms for patients with HER2-positive and HER2-negative metastatic gastric/GEJ cancer
  • Current role of anti-PD-1 antibodies for patients with recurrent metastatic gastric/GEJ cancer
  • Recent FDA approval of trastuzumab deruxtecan for HER2-positive advanced gastric or GEJ adenocarcinoma and key findings from the pivotal DESTINY-Gastric01 study; optimal integration into the treatment algorithm
  • Frequency of FGFR2b overexpression in gastroesophageal cancers
  • Mechanism of action, available and emerging data and potential clinical role of bemarituzumab for FGFR2b-overexpressing gastric or GEJ cancer
  • FDA approval and patient selection for TAS-102 for metastatic gastric/GEJ cancer

A patient with relapsed squamous cell carcinoma of the esophagus

  • Data sets (eg, KEYNOTE-181, ATTRACTION-3) defining the current role of anti-PD-1 antibodies for patients with advanced or recurrent esophageal cancer
  • Design, eligibility criteria and primary findings from the Phase III KEYNOTE-590 study evaluating first-line pembrolizumab combined with chemotherapy versus chemotherapy alone for advanced esophageal cancer; potential role in clinical practice
  • Available efficacy and safety outcomes and potential clinical implications of the CheckMate 577 study demonstrating a disease-free advantage with adjuvant nivolumab for patients with resected esophageal or GEJ cancer

A patient with newly diagnosed advanced hepatocellular carcinoma (HCC)

  • Clinical and biologic factors affecting the selection of first-line treatment for advanced HCC (eg, patient age, symptomatology, liver function)
  • Available data with and current clinical role of TKI monotherapy (eg, sorafenib, lenvatinib) as first-line therapy for unresectable HCC
  • Design, entry criteria and key efficacy and safety findings of the Phase III IMbrave150 trial comparing first-line atezolizumab/bevacizumab to sorafenib for unresectable HCC
  • FDA approval and optimal integration of atezolizumab/bevacizumab as first-line therapy for unresectable HCC
  • Results from the Phase III ORIENT-32 trial evaluating the anti-PD-1 antibody sintilimab in combination with a bevacizumab biosimilar as first-line treatment for advanced HCC
  • Available data with and ongoing evaluation of other novel combination strategies (eg, lenvatinib/pembrolizumab, lenvatinib/nivolumab, cabozantinib/atezolizumab, cabozantinib/nivolumab/ipilimumab) for advanced HCC

A patient with HCC who experiences disease progression on first-line atezolizumab/bevacizumab

  • Key factors in the selection and sequencing of approved regimens for patients whose disease has progressed on first-line therapy
  • Long-term outcomes with approved anti-angiogenic agents (eg, regorafenib, cabozantinib, ramucirumab) for patients with progressive HCC
  • Published efficacy and safety data with single-agent immune checkpoint inhibitor therapy for patients with relapsed HCC
  • Efficacy and safety findings from the CheckMate 040 trial leading to the FDA approval of nivolumab/ipilimumab for patients with progressive HCC; current clinical role

A patient with advanced cholangiocarcinoma and an activating FGFR2 rearrangement

  • Efficacy and safety findings contributing to the FDA approval of the selective FGFR inhibitor pemigatinib for patients with pretreated cholangiocarcinoma with an FGFR2 translocation; ongoing Phase III evaluation in treatment-naïve disease
  • Available evidence with other FGFR-targeted agents (eg, futibatinib, infigratinib, erdafitinib) for advanced or unresectable cholangiocarcinoma
  • Outcomes from the Phase III ClarIDHy study evaluating the IDH1 inhibitor ivosidenib for patients with previously treated cholangiocarcinoma with an IDH1 mutation; implications for research and practice

A patient with localized pancreatic adenocarcinoma (PAD)

  • Available clinical trial data evaluating the utility of contemporary cytotoxic regimens (mFOLFIRINOX, nab paclitaxel/gemcitabine) as preoperative therapy for resectable or borderline-resectable PAD
  • Selection of adjuvant systemic therapy for patients with resected PAD
  • Key efficacy results from the Phase III APACT trial evaluating adjuvant nab paclitaxel/gemcitabine versus gemcitabine alone; clinical applicability of the results

A patient with metastatic PAD

  • Optimal selection of first- and later-line treatment for metastatic PAD; importance of age, comorbidities and prior therapy
  • Early front-line activity observed with the combination of nanoliposomal irinotecan (nal-IRI), 5-FU/leucovorin and oxaliplatin (NALIRIFOX) in patients with metastatic PAD
  • Patient selection for and practical integration of nal-IRI for relapsed metastatic PAD
  • Design, entry criteria and key efficacy and safety findings from the Phase III POLO trial evaluating olaparib as maintenance therapy for patients with metastatic PAD and a germline BRCA mutation after first-line chemotherapy
  • FDA approval of maintenance olaparib and implications for genetic testing and current nonresearch care of patients with metastatic PAD with BRCA mutations

Acute Myeloid Leukemia and Myelodysplastic Syndromes | 4:15 PM – 5:15 PM ET (1:15 PM – 2:15 PM PT)

Case presentations and topics to be discussed

An older patient with newly diagnosed acute myeloid leukemia (AML) who is not eligible for intensive induction chemotherapy

  • Published data supporting the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine (LDC) for patients with newly diagnosed AML aged 75 years or older or those who are not candidates for intensive induction chemotherapy
  • Design, eligibility criteria and key efficacy and safety findings from the Phase III VIALE-A and VIALE-C trials evaluating venetoclax in combination with azacitidine and LDC, respectively, as first-line treatment for patients with AML who are ineligible for intensive chemotherapy
  • Incidence of tumor lysis syndrome and other adverse events associated with the use of venetoclax in AML clinical trials; implications for the implementation of prophylactic measures in routine practice

A younger patient with newly diagnosed AML and poor-risk cytogenetics

  • Historical outcomes with intensive induction chemotherapy for patients with AML and unfavorable prognostic features (eg, complex karyotype, TP53 mutation)
  • Ongoing investigation of venetoclax for younger, fit patients with newly diagnosed AML; current off-protocol role for high-risk disease
  • Rationale for the investigation of CC-486 as maintenance therapy for patients with AML who have responded to intensive induction chemotherapy but not undergone transplant; pharmacologic differences between CC-486 and injectable azacitidine
  • Design, entry criteria and key efficacy and safety outcomes of the Phase III QUAZAR AML-001 study assessing CC-486 as maintenance therapy
  • Recent FDA approval of CC-486; implications for routine practice and future research

A patient with R/R AML with a FLT3 mutation

  • Clinical trial database underlying the FDA approval of midostaurin and optimal incorporation into current AML management
  • Design, eligibility criteria and key efficacy and safety outcomes of the Phase III ADMIRAL trial comparing gilteritinib to salvage chemotherapy for patients with R/R AML with FLT3 mutations; FDA-approved indication for gilteritinib and appropriate integration into practice
  • Available data with gilteritinib combined with standard induction/consolidation chemotherapy for newly diagnosed AML; ongoing investigation of gilteritinib in the front-line setting
  • Recognition and management of common and less frequent adverse events observed with the use of midostaurin and gilteritinib

An older patient with newly diagnosed AML with an IDH1 mutation

  • Efficacy and safety findings leading to the FDA approval of ivosidenib for patients with newly diagnosed AML with IDH1 mutations who are at least 75 years old or have comorbidities that preclude the use of intensive induction chemotherapy
  • Long-term follow-up data supporting the FDA approvals of ivosidenib and enasidenib for R/R AML
  • Activity and safety with the use of enasidenib as monotherapy and in combination with chemotherapy for patients with newly diagnosed AML and an IDH2 mutation
  • Incidence, presentation and management of differentiation syndrome and other adverse events with IDH inhibitors

A patient with intermediate-risk myelodysplastic syndrome (MDS)

  • Design, eligibility criteria and key endpoints of the ASTX727-01-B and ASTX727-02 (ASCERTAIN) studies evaluating the oral combination of decitabine and cedazuridine for MDS
  • Response rates, duration of response and rates of transfusion independence achieved with oral decitabine/cedazuridine; FDA approval and current clinical role compared to standard IV decitabine
  • Key efficacy and safety endpoints achieved in the randomized Phase III MEDALIST trial leading to the FDA approval of luspatercept for the management of MDS-associated anemia; optimal patient selection and timing of introduction
  • Activity observed with approved AML therapies (eg, venetoclax, ivosidenib, enasidenib, CC-486) in patients with MDS; current off-protocol role
  • Magrolimab for MDS: Mechanism of action, available data, FDA breakthrough therapy designation and potential clinical role; activity in AML
  • Biologic rationale for the investigation of pevonedistat in combination with azacitidine for higher-risk MDS; ongoing evaluation and potential clinical role
  • Available data with and ongoing evaluation of other promising agents for MDS (eg, eprenetapopt)

A patient with AML secondary to MDS transformation

  • Mechanism of action of CPX-351; rationale for its higher activity in patients with secondary AML
  • Long-term efficacy and safety observed with CPX-351 in the pivotal Phase III trial comparing it to standard 7 + 3 for newly diagnosed secondary AML; optimal integration into practice
  • Published efficacy findings with and ongoing and planned clinical trials evaluating CPX-351 in the treatment of primary AML and in combination with other agents

PROGRAM BREAK | 5:15 PM – 5:35 PM ET (2:15 PM – 2:35 PM PT)

Lung Cancer | 5:35 PM – 6:35 PM ET (2:35 PM – 3:35 PM PT)

Case presentations and topics to be discussed

A patient with localized or locally advanced non-small cell lung cancer (NSCLC)

  • Design, eligibility criteria and primary and secondary endpoints of the Phase III CheckMate 816 trial evaluating nivolumab in combination with chemotherapy as neoadjuvant therapy for patients with resectable NSCLC
  • Emerging findings indicating improved rates of pathologic complete response with the addition of nivolumab to neoadjuvant chemotherapy in CheckMate 816; clinical implications
  • Long-term efficacy and safety findings from the Phase III PACIFIC trial evaluating consolidation durvalumab after chemoradiation therapy for unresectable Stage III NSCLC
  • Role of durvalumab consolidation for patients with locally advanced NSCLC and low PD-L1 expression or targetable genomic alterations
  • Spectrum, incidence, timing and severity of toxicities, including immune-related adverse events, with consolidation durvalumab in patients with locally advanced NSCLC
  • Other ongoing and planned clinical trials of immune checkpoint inhibitors for nonmetastatic NSCLC

A patient with newly diagnosed extensive-stage small cell lung cancer (SCLC)

  • Design, eligibility criteria and key efficacy and safety findings from the pivotal Phase III IMpower133 and CASPIAN trials evaluating atezolizumab and durvalumab, respectively, in combination with chemotherapy for previously untreated extensive-stage SCLC
  • Appropriate integration of first-line carboplatin/etoposide/atezolizumab and platinum/etoposide/durvalumab into SCLC management
  • Available clinical trial data with and current role of immune checkpoint inhibitors for progressive early-stage SCLC
  • Design, eligibility criteria and major efficacy and safety findings of the Phase II basket trial assessing lurbinectedin for patients with SCLC who experienced disease progression after prior platinum-based therapy; recent FDA approval and current clinical role
  • Clinical and research implications, if any, of emerging data from the Phase III ATLANTIS study indicating no improvement in overall survival with lurbinectidin in combination with doxorubicin for patients with SCLC whose disease progressed after 1 prior line of platinum-containing therapy

A patient with early-stage NSCLC with an EGFR exon 19 deletion mutation

  • Recent FDA approval of adjuvant osimertinib for early-stage NSCLC with an EGFR mutation after complete tumor resection; key safety and efficacy findings from the pivotal ADAURA study
  • Available efficacy and safety results from ADAURA; implications for biomarker testing and clinical care
  • Optimal first-line treatment for patients with NSCLC with EGFR tumor mutations; overall and progression-free survival benefit observed with up-front osimertinib
  • Incidence, clinical relevance and spectrum of resistance mechanisms in patients experiencing disease progression on osimertinib
  • Key efficacy and safety findings from the Phase III RELAY study leading to the FDA approval of erlotinib in combination with ramucirumab for previously untreated metastatic NSCLC with an EGFR mutation
  • Clinical trial findings with anti-PD-1/PD-L1 antibodies for NSCLC with an EGFR mutation; effect of prior immune checkpoint inhibition on the tolerability of EGFR TKI therapy
  • Available data with novel agents and strategies targeting EGFR exon 20 mutations (eg, mobocertinib, amivantamab, high-dose osimertinib); FDA breakthrough therapy designations for mobocertinib and amivantamab and development plans

A patient with metastatic NSCLC with an ALK rearrangement

  • Optimal selection of first- and later-line therapy for patients with metastatic NSCLC with an ALK rearrangement
  • Long-term efficacy and safety outcomes with first-line alectinib or brigatinib for NSCLC with an ALK rearrangement
  • Available findings from the Phase III CROWN and eXalt3 trials demonstrating a progression-free survival advantage with first-line lorlatinib and ensartinib, respectively, compared to crizotinib for NSCLC with an ALK rearrangement
  • Similarities and differences in the clinicopathologic features of patients with NSCLC with ROS1 rearrangements and those with ALK rearrangements
  • Pooled findings from the STARTRK-2, STARTRK-1 and ALKA-372-001 trials demonstrating the efficacy and safety of entrectinib in patients with NSCLC with ROS1 rearrangements; FDA approval and appropriate integration into clinical practice
  • Intracranial response rates observed with entrectinib in patients with NSCLC with ROS1 rearrangements and CNS involvement; implications for clinical care

A patient with metastatic NSCLC who experiences disease progression on first-line carboplatin/pemetrexed/pembrolizumab and undergoes next-generation sequencing

  • Frequency of other targetable mutations (eg, RET, MET exon 14, HER2, KRAS) in metastatic NSCLC; optimal testing protocols
  • Available safety and efficacy results from the LIBRETTO-001 trial leading to the FDA approval of selpercatinib for RET fusion-driven NSCLC; optimal integration into clinical practice
  • Clinical activity and safety of pralsetinib in patients with advanced NSCLC and RET fusions reported in the Phase I/II ARROW study; recent FDA approval and current clinical role
  • Design, eligibility criteria and key findings from the Phase II GEOMETRY mono-1 trial assessing capmatinib for NSCLC with a MET exon 14 mutation; recent FDA approval and role in current clinical practice
  • Recent FDA approval of tepotinib for metastatic NSCLC with a MET exon 14 mutation and key findings from the pivotal VISION study
  • Key findings from the Phase II DESTINY-Lung01 study evaluating trastuzumab deruxtecan for NSCLC with a HER2 mutation; FDA breakthrough therapy designation and potential nonresearch role
  • Available safety and efficacy data with sotorasib for advanced NSCLC with a KRAS G12C mutation; FDA breakthrough therapy designation, ongoing evaluation and potential clinical role

A patient with newly diagnosed metastatic NSCLC with no actionable tumor mutation

  • Clinical trial database supporting the FDA approvals of pembrolizumab and atezolizumab administered as monotherapy and combined with chemotherapy as first-line treatment for metastatic NSCLC
  • Current clinical role of atezolizumab in combination with carboplatin/paclitaxel/bevacizumab as first-line therapy for patients with metastatic nonsquamous NSCLC
  • Phase III clinical trial results (CheckMate 227, CheckMate 9LA) leading to the recent FDA approvals of first-line nivolumab/ipilimumab with and without chemotherapy; patient selection and optimal integration into practice
  • Available efficacy and safety data from the Phase III EMPOWER-Lung 1 trial of first-line cemiplimab monotherapy for patients with NSCLC and PD-L1 in ≥50% of tumor cells; FDA priority review status and potential clinical role
  • Management of disease that has progressed on anti-PD-1/PD-L1-based therapy in the first-line setting; current role of approved agents and regimens (eg, ramucirumab, afatinib, bevacizumab)

PROGRAM ADJOURNS

CE Information

Target Audience
This live activity has been designed to meet the educational needs of medical oncologists, hematologists, hematology-oncology fellows, nurse practitioners, clinical nurse specialists and other allied cancer professionals involved in the treatment of cancer.

Learning Objectives

BREAST CANCER

  • Evaluate published research data to guide the selection and duration of neoadjuvant, adjuvant and extended adjuvant therapy for patients with HER2-overexpressing localized breast cancer.
  • Implement a long-term clinical plan for the management of metastatic HER2-positive breast cancer, incorporating existing and recently approved anti-HER2 therapies.
  • Recognize common and rare side effects associated with novel anti-HER2 agents, and develop supportive management plans for patients undergoing treatment for HER2-positive breast cancer.
  • Evaluate the results of genomic assays and other patient- and treatment-related factors to personalize the use of adjuvant systemic therapy for newly diagnosed ER-positive breast cancer.
  • Consider available and emerging clinical trial findings with CDK4/6 inhibitors for localized ER-positive, HER2-negative breast cancer, and assess the potential role of these agents as neoadjuvant or adjuvant treatment.
  • Individualize the selection and sequence of systemic therapy for patients with ER-positive metastatic breast cancer, considering age, menopausal status, prior treatment, PIK3CA mutation status, comorbidities, symptomatology and extent and sites of disease.
  • Review published research data supporting the benefit of chemotherapy in combination with anti-PD-1/PD-L1 antibodies for patients with newly diagnosed PD-L1-positive metastatic triple-negative breast cancer (TNBC), and use this information to make appropriate treatment recommendations.
  • Recall available research data and ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies for localized TNBC, and determine the current and potential role of these strategies in clinical practice.
  • Assess potential biomarkers of response to PARP inhibition, and use this information to optimize the selection of available genetic testing platforms and related therapeutic interventions for patients with metastatic breast cancer.
  • Appraise recent FDA approvals of and ongoing clinical research studies evaluating novel agents and treatment strategies for various forms of breast cancer, and counsel patients about protocol and nonresearch treatment opportunities.

MULTIPLE MYELOMA

  • Customize the use of induction, consolidation and maintenance therapeutic approaches for multiple myeloma (MM) in the transplant and nontransplant settings, considering patient- and disease-related factors, including cytogenetic profile.
  • Appreciate clinical trial data informing the front-line use of monoclonal antibody therapy directed at CD38 for patients with MM eligible or ineligible for stem cell transplant, and effectively identify when and how this strategy should be integrated into clinical management.
  • Recognize published research data validating the use of minimal residual disease (MRD) status as a mechanism to predict long-term outcomes with therapy, and use this information to determine the potential role of MRD assays in the protocol and off-protocol management of MM.
  • Consider published research findings and other clinical factors in the best-practice selection, sequencing and combining of established regimens in the care of patients with relapsed/refractory MM.
  • Develop an understanding of the mechanisms of action of and pivotal clinical trial findings with recently FDA-approved novel therapies (eg, isatuximab, selinexor, belantamab mafodotin) to facilitate their integration into MM management algorithms.
  • Appreciate available data documenting the activity of chimeric antigen receptor T-cell therapy targeting BCMA in MM, and use this knowledge to identify patients who may be appropriate for a clinical trial of this approach.
  • Recall the design of ongoing clinical trials evaluating novel agents and strategies for MM, and counsel appropriate patients about availability and participation.

CHRONIC LYMPHOCYTIC LEUKEMIA AND LYMPHOMAS

  • Individualize the selection and sequencing of systemic therapy for patients with newly diagnosed or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), considering clinical presentation, age, performance status (PS), biomarker profile and coexisting medical conditions.
  • Understand published research data informing the selection, sequencing or combining of available therapeutic agents in the nonresearch care of patients with previously untreated or R/R follicular lymphoma (FL).
  • Recognize the mechanisms of action, efficacy and safety of approved and investigational agents for the treatment of diffuse large B-cell lymphoma (DLBCL) to determine the current and potential utility of those agents in clinical practice.
  • Consider patient age, PS and other clinical and biologic factors in the up-front and subsequent treatment of mantle cell lymphoma (MCL).
  • Incorporate new therapeutic strategies into the best-practice management of newly diagnosed and R/R Hodgkin lymphoma (HL).
  • Implement a plan of care to recognize and manage side effects and toxicities associated with existing and recently approved systemic therapies for CLL, FL, MCL, DLBCL and HL to support quality of life and continuation of treatment.
  • Recall new data with agents and strategies currently under investigation for CLL and various lymphoma subtypes, and discuss ongoing trial opportunities with eligible patients.

GENITOURINARY CANCERS

  • Evaluate the published research database supporting the FDA approvals of secondary hormonal agents in the management of nonmetastatic castration-resistant prostate cancer (CRPC), and apply this information in the recommendation of nonresearch treatment options for patients.
  • Explore available data with cytotoxic and secondary hormonal therapy for metastatic hormone-sensitive prostate cancer to design effective treatment plans for patients.
  • Apply clinical research findings in the determination of best-practice selection and sequencing of available treatment modalities for patients with metastatic CRPC.
  • Evaluate the recent FDA approvals of olaparib and rucaparib for patients with metastatic CRPC, and optimally incorporate these agents into clinical management algorithms.
  • Consider published and emerging research information, clinical investigator perspectives and available guideline recommendations to individualize first-line therapy for patients with advanced renal cell carcinoma (RCC).
  • Develop a rational approach to the sequencing of systemic therapies for patients with advanced RCC who experience disease progression on first-line treatment, incorporating multikinase inhibitors, mTOR inhibitors and immunotherapeutic agents.
  • Recognize available clinical trial evidence with immune checkpoint inhibitors for nonmetastatic urothelial bladder carcinoma (UBC) to determine the current and potential utility of this strategy in clinical practice.
  • Review available clinical trial data with anti-PD-1/PD-L1 antibodies for patients with newly diagnosed or relapsed/refractory metastatic UBC in order to optimally incorporate these agents into management algorithms.
  • Recall the mechanisms of action of and pivotal clinical trial findings with enfortumab vedotin and erdafitinib for previously treated locally advanced or metastatic UBC, and identify patients for whom treatment with these novel compounds would be appropriate.
  • Appraise available research data and ongoing clinical trials evaluating novel agents and strategies for prostate cancer, RCC and UBC, and counsel appropriately selected patients about participation in active research protocols.

GASTROINTESTINAL CANCERS

  • Develop individual long-term care plans for patients diagnosed with metastatic colorectal cancer, considering biomarker profile, tumor location, prior exposure to systemic therapy, symptomatology, performance status (PS) and personal goals for treatment.
  • Use HER2 status, PD-L1 combined positive score and other clinical and biologic factors to optimize the selection and sequence of systemic therapy for patients with locally advanced or metastatic gastric, gastroesophageal junction or esophageal cancer.
  • Consider age, PS, liver function and other clinical factors in the selection of first- and later-line therapy for patients with unresectable or metastatic hepatocellular carcinoma.
  • Recall clinical trial data with approved and investigational systemic interventions for patients with localized, locally advanced or metastatic pancreatic adenocarcinoma, and establish an evidence-based approach to selecting therapy.
  • Appreciate the molecular heterogeneity of cholangiocarcinomas, and apply available clinical research findings in the formulation of individualized therapeutic approaches for patients with unresectable and metastatic disease.
  • Appraise available and emerging data with investigational agents currently in clinical testing for gastrointestinal cancers, and refer eligible patients for clinical trial participation.

ACUTE MYELOID LEUKEMIA AND MYELODYSPLASTIC SYNDROMES

  • Evaluate the importance of patient age, performance status and other biologic and disease-related factors in the selection and sequencing of therapy for various presentations of acute myeloid leukemia (AML).
  • Appreciate the FDA approval of venetoclax in combination with azacitidine, decitabine or low-dose cytarabine for patients with newly diagnosed AML ineligible for intensive therapy, and identify individuals appropriate for treatment with this novel agent.
  • Assess the FDA-approved indications for CPX-351 in patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes, and discern how this agent can be safely and optimally integrated into nonresearch care algorithms.
  • Review Phase III data documenting the efficacy of CC-486 as maintenance therapy for patients with newly diagnosed AML who achieved first complete response or complete response with incomplete blood count recovery with induction chemotherapy, and consider how this novel strategy can be applied in clinical management.
  • Reflect on available research evidence with approved and emerging FLT3 inhibitors, and use this information to guide clinical care and protocol opportunities for appropriate patients with newly diagnosed or progressive AML harboring a FLT3 mutation.
  • Develop an understanding of the mechanisms of action of, available data with and current role for available IDH1/2 inhibitors for patients with newly diagnosed or relapsed/refractory AML and an IDH1 or 2 mutation.
  • Formulate a treatment algorithm for lower- and higher-risk myelodysplastic syndromes (MDS), considering patient- and disease-related factors, including cytogenetic abnormalities.
  • Recognize the recent FDA approval of the combination of decitabine and cedazuridine for intermediate- and high-risk MDS, and identify patients for whom treatment with this novel approach may be appropriate.
  • Describe the biologic rationale for and mechanism of action of luspatercept in the treatment of anemia secondary to MDS, and appraise how this agent can be appropriately integrated into clinical practice.
  • Recall promising agents and combination strategies under investigation for AML and MDS, and counsel appropriately selected patients regarding clinical trial enrollment.

LUNG CANCER

  • Analyze the biologic basis for the investigation of immune checkpoint inhibitors for nonmetastatic non-small cell lung cancer (NSCLC), and evaluate available and emerging data documenting the efficacy and safety of anti-PD-1/PD-L1 antibody-based approaches as neoadjuvant or adjuvant therapy.
  • Appraise the FDA approval of anti-PD-L1 antibody consolidation therapy for patients with unresectable Stage III NSCLC who have not experienced disease progression after standard platinum-based chemotherapy concurrent with radiation therapy, and discern how this strategy can be appropriately and safely integrated into routine clinical practice.
  • Appreciate available clinical trial findings informing the use of immune checkpoint inhibitors in combination with platinum-based chemotherapy for patients with previously untreated extensive-stage small cell lung cancer (SCLC).
  • Design an optimal approach to the clinical care of patients with progressive SCLC, considering the implications of prior therapeutic exposure, symptomatology and other factors.
  • Acknowledge available Phase III findings supporting the use of adjuvant osimertinib for patients with early-stage NSCLC with EGFR mutations, and consider the potential effect of this information on clinical practice.
  • Review published data documenting the safety and efficacy of EGFR tyrosine kinase inhibitors alone or in combination with other systemic approaches for metastatic NSCLC with an EGFR tumor mutation, and discern how this information should be applied outside of a research setting.
  • Assess the efficacy and safety of commercially available ALK inhibitors for patients with metastatic NSCLC with ALK rearrangements, and apply this understanding to the selection and sequencing of these drugs as first- and later-line therapy.
  • Recollect other oncogenic pathways (eg, ROS1, RET, MET, HER2, KRAS) mediating the pathogenesis of tumors in unique patient subsets, and recall published and emerging data with commercially available and experimental agents exploiting these targets.
  • Review recent therapeutic advances related to the use of anti-PD-1/PD-L1 antibodies as monotherapy or in combination with chemotherapy or chemobiologic therapy for metastatic NSCLC, and discern how these approaches can be optimally employed in the management of this disease.
  • Recognize the recent FDA approvals of nivolumab in combination with ipilimumab with and without chemotherapy as first-line treatment for metastatic NSCLC, and appropriately incorporate these novel regimens into treatment algorithms.

Accreditation Statements
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Research To Practice is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation (ANCC).

CME Credit Designation Statement
Research To Practice designates this live activity for a maximum of 7 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CME and ABIM MOC credit form links will be emailed to each participant within 5 business days of the activity.

NCPD Credit Designation Statements
This educational activity for 7 contact hours is provided by Research To Practice.

This activity is awarded 7 ANCC pharmacotherapeutic contact hours.

To obtain a certificate of completion and receive credit for this event, nurses must return a completed Educational Assessment and Credit Form for the modules they attend. The credit form links will be emailed to participants within 5 business days of the activity.

American Board of Internal Medicine (ABIM) — Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 7 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialties: medical oncology and hematology.

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Oncology Nursing Certification Corporation (ONCC)/Individual Learning Needs Assessment (ILNA) Certification Information
This activity will be submitted to the ONCC for ILNA verification.

Unlabeled/Unapproved Uses Notice
There is no implied or real endorsement of any product by Research To Practice, ACCME or the ANCC. Any off-label use as declared by the FDA will be identified.

Content Validation and Disclosures
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME/NCPD activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTYDr Pal has no relevant conflicts of interest to disclose. The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Dr O’ReganAdvisory Committee and Consulting Agreements: bioTheranostics Inc, Cyclacel Pharmaceuticals Inc, Lilly, MacroGenics Inc, Novartis, Pfizer Inc, Puma Biotechnology Inc, Seagen Inc; Contracted Research: Puma Biotechnology Inc; Data and Safety Monitoring Board/Committee: Immunomedics Inc. Dr TrainaConsulting Agreements: Aduro Biotech, Advaxis Inc, AstraZeneca Pharmaceuticals LP, Athenex Inc, Bristol-Myers Squibb Company, Celgene Corporation, Daiichi Sankyo Inc, Exact Sciences Inc, Genentech, a member of the Roche Group, Halozyme Inc, Innocrin Pharmaceuticals Inc, Ionis Pharmaceuticals Inc, Merck, Pfizer Inc, Puma Biotechnology Inc, Samsung Bioepis, Seagen Inc; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Carrick Therapeutics, Daiichi Sankyo Inc, Eisai Inc, Genentech, a member of the Roche Group, Immunomedics Inc, Innocrin Pharmaceuticals Inc, Novartis, Pfizer Inc; Speakers Bureau: Genentech, a member of the Roche Group. Dr CamidgeConsulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, Eisai Inc, EMD Serono Inc, GlaxoSmithKline, Helsinn Healthcare SA, Janssen Biotech Inc, Lilly, Mersana Therapeutics, OnKure, Pfizer Inc, Qilu Pharmaceutical Co Ltd, Roche Laboratories Inc, Sanofi Genzyme, Seagen Inc, Takeda Oncology, Turning Point Therapeutics; Data and Safety Monitoring Board/Committee: AstraZeneca Pharmaceuticals LP, Bio-Thera Solutions; ILD Adjudication Committee: Daiichi Sankyo Inc; Scientific Advisory Board: Amgen Inc, Anchiano Therapeutics, Apollomics Inc, Elevation Oncology, Kestrel, Nuvalent. Dr LevyAdvisory Committee and Consulting Agreements: AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Janssen Biotech Inc, Lilly, Merck, Pfizer Inc, Takeda Oncology; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, Merck. Dr MessersmithContracted Research: ALX Oncology, BeiGene Ltd, Bristol-Myers Squibb Company, Exelixis Inc, Experimental Drug Development Centre (Singapore), Immunomedics Inc, Pfizer Inc, Mitsubishi Tanabe Pharma America; Data and Safety Monitoring Board/Committee: Five Prime Therapeutics Inc, QED Therapeutics, Zymeworks. Dr O’ReillyConsulting Agreements: Agios Pharmaceuticals Inc, AstraZeneca Pharmaceuticals LP, Autem Medical, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Berry Genomics, Celgene Corporation, CytomX Therapeutics, Debiopharm Group, Eisai Inc, Exelixis Inc, Flatiron Health, Genentech, a member of the Roche Group, Gilead Sciences Inc, HelioHealth, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, MiNA Therapeutics, Polaris Group, QED Therapeutics, RedHill Biopharma Ltd, Silenseed Ltd, SillaJen, Sobi, TheraBionic, twoXAR, Vector Pharma, Yiviva; Contracted Research: ActaBiológica, Agios Pharmaceuticals Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Berry Genomics, Bristol-Myers Squibb Company, CASI Pharmaceuticals Inc, Celgene Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Halozyme Inc, Incyte Corporation, MabVax Therapeutics, Puma Biotechnology Inc, QED Therapeutics, SillaJen, Yiviva. Dr BellmuntAdvisory Committee and Consulting Agreements: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, Merck, Pfizer Inc; Contracted Research: Merck, Pfizer Inc, Takeda Oncology. Dr AndersonAdvisory Committee: Amgen Inc, AstraZeneca Pharmaceuticals LP, Janssen Biotech Inc, Pfizer Inc; Consulting Agreements: Mana Therapeutics, Precision BioSciences, Raqia Therapeutics Inc, WindMIL Therapeutics; Scientific Founder: C4 Therapeutics, OncoPep. Dr RajeConsulting Agreements: Amgen Inc, bluebird bio, Celgene Corporation. Dr ErbaAdvisory Committee and Consulting Agreements: AbbVie Inc, Agios Pharmaceuticals Inc, Astellas, Bristol-Myers Squibb Company, Celgene Corporation, Daiichi Sankyo Inc, Genentech, a member of the Roche Group, GlycoMimetics Inc, Incyte Corporation, Jazz Pharmaceuticals Inc, Kura Oncology, Novartis, Syros Pharmaceuticals Inc, Takeda Oncology, Trillium Therapeutics Inc. Contracted Research: AbbVie Inc, Agios Pharmaceuticals Inc, ALX Oncology, Amgen Inc, Daiichi Sankyo Inc, FORMA Therapeutics, Forty Seven Inc, Gilead Sciences Inc, GlycoMimetics Inc, ImmunoGen Inc, Jazz Pharmaceuticals Inc, MacroGenics Inc, Novartis, PTC Therapeutics; Independent Review Committee: AbbVie Inc; Speakers Bureau: AbbVie Inc, Agios Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Incyte Corporation, Jazz Pharmaceuticals Inc, Novartis. Dr KomrokjiAdvisory Committee: Bristol-Myers Squibb Company, Celgene Corporation, Gilead Sciences Inc, Innovent, Novartis, PharmaEssentia, Taiho Oncology Inc; Consulting Agreements: AbbVie Inc, Acceleron Pharma, Agios Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Geron, Incyte Corporation, Jazz Pharmaceuticals Inc, Novartis, Pfizer Inc; Speakers Bureau: AbbVie Inc, Agios Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Jazz Pharmaceuticals Inc. Dr MoskowitzContracted Research: ADC Therapeutics SA, AstraZeneca Pharmaceuticals LP, Incyte Corporation, Merck, Seagen Inc; Scientific Advisory Board: AstraZeneca Pharmaceuticals LP, Incyte Corporation, Merck, Molecular Templates, Seagen Inc, Takeda Oncology. Dr SharmanAdvisory Committee, Consulting Agreements and Contracted Research: AbbVie Inc, AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Pharmacyclics LLC, an AbbVie Company, TG Therapeutics Inc.

MODERATORDr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: AbbVie Inc, Adaptive Biotechnologies Corporation, Agios Pharmaceuticals Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Eisai Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Kite, A Gilead Company, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Novartis, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seagen Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Turning Point Therapeutics Inc and Verastem Inc.

Research To Practice CME/NCPD Planning Committee Members, Staff and Reviewers — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

Supporters
This activity is supported by educational grants from AbbVie Inc, Astellas and Pfizer Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Blueprint Medicines, Daiichi Sankyo Inc, Epizyme Inc, Exact Sciences, Exelixis Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Karyopharm Therapeutics, Lilly, Merck, Novartis, Oncopeptides, Sanofi Genzyme, Seagen Inc and Taiho Oncology Inc.