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Integrating Biomarker Analyses into Clinical Decision-Making Regarding the Use of Immune Checkpoint Inhibitors in Cancer Treatment
Released July 2017

Proceedings from a CME symposium held at the 2017 AACR Annual Meeting. Featuring perspectives from Drs Johanna C Bendell, Charles G Drake, Roy S Herbst, David F McDermott and Craig Moskowitz. (Video Program)

CE Disclosures and Faculty Information

  • TARGET AUDIENCE
    This activity is intended for medical oncologists, hematologists, surgeons, radiation oncologists, oncology nurses and other healthcare professionals involved in basic, translational and clinical cancer research or treatment.

    OVERVIEW OF ACTIVITY
    The past several years have seen an explosion in the emergence of new therapies that leverage the natural ability of the human body to attack and treat cancer. The newest and perhaps most exciting arena in this regard has been the development and assessment of immune-modulating antibodies, or checkpoint immune modulators. To date studies with a number of anti-PD-1/PD-L1 monoclonal antibodies have demonstrated outcomes that many investigators have described as unprecedented, and emerging research data from an array of ongoing trials examining the role of these agents in a variety of diseases will almost certainly continue to dominate scientific congresses and the medical literature. Not surprisingly, the introduction of immune checkpoint inhibitors, particularly anti-PD-1/PD-L1 antibodies, has created a multitude of uncertainties and important clinical questions. Foremost among these is why certain patients enjoy profound and long-lasting benefits from these agents while others experience no clinical effect. This conundrum has impelled scientists to examine the biologic underpinnings of malignant cells and the cell environment in an effort to undercover potential biomarkers predictive of response to immunotherapeutic agents.

    These video proceedings from a CME symposium held during the 2017 AACR Annual Meeting feature discussions with renowned immunotherapy experts representing different areas of oncology — lung cancer, melanoma, gastrointestinal cancers, genitourinary cancers and hematologic cancers — regarding relevant clinical research exploring the burgeoning role of checkpoint inhibitors with an emphasis on what is known about the use of biomarkers to determine which patients will likely benefit from treatment with an immunotherapeutic agent. By providing information on important developments, this activity will assist medical oncologists and other healthcare professionals to address existing management uncertainties and determine the current and future roles of immunotherapeutic interventions.

    LEARNING OBJECTIVES

    • Appraise the rationale for and clinical data with approved anti-PD-1 and anti-PD-L1 antibodies in patients with various solid tumors and hematologic cancers.
    • Describe ongoing research to assist in the identification of biomarkers, tumor characteristics or other clinical features that are indicative of response to immune checkpoint inhibitors in patients with different types of cancer.
    • Compare and contrast expert perspectives on the indications for PD-L1 analysis in patients with metastatic non-small cell lung cancer, melanoma and other cancers, and, when appropriate, select individuals for PD-L1 assessment.
    • Appreciate the similarities and differences among various diagnostic assays available to determine PD-L1 status, and use this information to select a validated testing platform for use in practice.
    • Describe ongoing research to document the correlation between DNA mismatch repair deficiency in colorectal and noncolorectal gastrointestinal and other cancers and response to anti-PD-1 immune checkpoint inhibitors, and develop strategies to assess for this biomarker.
    • Recognize current investigational efforts to identify other potential biomarkers of response to checkpoint inhibition (tumor mutational burden, tumor-infiltrating lymphocytes, et cetera), and consider how they may be applied in future clinical practice.
    • Recall the design of ongoing clinical trials evaluating novel immunotherapeutic approaches, and counsel appropriately selected patients about availability and participation.

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

    CREDIT DESIGNATION STATEMENT
    Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in 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 2.25 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 specialty: medical oncology.

    Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

    HOW TO USE THIS CME ACTIVITY
    This CME activity consists of a video component. To receive credit, the participant should watch the video, complete the Post-test with a score of 80% or better and fill out the Educational Assessment and Credit Form located at ResearchToPractice.com/AACR17/CME.

    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 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.

    FACULTY — The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

    Johanna C Bendell, MD
    Director, GI Oncology Research 
    Associate Director
    Drug Development Unit 
    Sarah Cannon Research Institute 
    Nashville, Tennessee 

    Contracted Research: Abbott Laboratories, AbbVie Inc, Apexigen, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Daiichi Sankyo Inc, Eisai Inc, EMD Serono Inc, Five Prime Therapeutics Inc, Forty Seven Inc, Genentech BioOncology, Gilead Sciences Inc, GlaxoSmithKline, Incyte Corporation, Kolltan Pharmaceuticals Inc, Leap Therapeutics Inc, Lilly, MacroGenics Inc, MedImmune Inc, Merck, Novartis, OncoMed Pharmaceuticals Inc, Onyx Pharmaceuticals, an Amgen subsidiary, Pfizer Inc, Roche Laboratories Inc, Sanofi Genzyme, Stemcentrx, Taiho Oncology Inc, Takeda Oncology, TG Therapeutics Inc.

    Charles G Drake, MD, PhD
    Professor of Medicine 
    Co-Director
    Cancer Immunotherapy Programs
    Columbia University Medical Center
    New York, New York

    Consulting Agreements: Agenus Inc, Dendreon Pharmaceuticals Inc, Genentech BioOncology, ImmuneXcite, Janssen Biotech Inc, Lilly, Merck, NexImmune, Pierre Fabre, Roche Laboratories Inc; Contracted Research: Bristol-Myers Squibb Company; Patents: AstraZeneca Pharmaceuticals LP, Janssen Biotech Inc, MedImmune Inc; Scrip Regulatory Affairs: Aduro Biotech, Bristol-Myers Squibb Company, Janssen Biotech Inc; Stock Ownership: Compugen, NexImmune, Potenza Therapeutics, Tizona Therapeutics.

    Roy S Herbst, MD, PhD
    Ensign Professor of Medicine (Oncology)
    Professor of Pharmacology
    Chief of Medical Oncology
    Director, Thoracic Oncology Research Program
    Associate Director for Translational Research
    Yale Comprehensive Cancer Center 
    Yale School of Medicine
    Smilow Cancer Hospital
    New Haven, Connecticut

    Consulting Agreements: AstraZeneca Pharmaceuticals LP, Genentech BioOncology, Kolltan Pharmaceuticals Inc, Lilly, Merck, Pfizer Inc; Contracted Research: Genentech BioOncology, Merck.

    David F McDermott, MD
    Associate Professor of Medicine
    Harvard Medical School
    Director, Biologic Therapy and Cutaneous Oncology Programs
    Beth Israel Deaconess Medical Center
    Leader, Kidney Cancer Program
    Dana-Farber Cancer Center
    Boston, Massachusetts

    Consulting Agreements: Array BioPharma Inc, Bristol-Myers Squibb Company, Eisai Inc, Exelixis Inc, Genentech BioOncology, Merck, Novartis, Pfizer Inc; Contracted Research: Prometheus Laboratories Inc.

    Craig Moskowitz, MD
    Clinical Director, Division of Hematologic Oncology 
    Attending Physician
    Lymphoma and Adult BMT Services
    Member, Memorial Sloan Kettering Cancer Center 
    Professor of Medicine
    Weill Medical College of Cornell University 
    New York, New York

    Consulting Agreements: Bristol-Myers Squibb Company, Celgene Corporation, Genentech BioOncology, Merck, Seattle Genetics; Contracted Research: Bristol-Myers Squibb Company, Merck, Pharmacyclics LLC, an AbbVie Company, Seattle Genetics.

    MODERATOR — Dr Love is president and CEO of Research To Practice, which receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Acerta Pharma, Adaptive Biotechnologies, Agendia Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Inc, Astellas Pharma Global Development Inc, AstraZeneca Pharmaceuticals LP, Baxalta Inc, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, CTI BioPharma Corp, Dendreon Pharmaceuticals Inc, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech BioOncology, Genomic Health Inc, Gilead Sciences Inc, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Kite Pharma Inc, Lexicon Pharmaceuticals Inc, Lilly, Medivation Inc, a Pfizer Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, NanoString Technologies, Natera Inc, Novartis, Novocure, Onyx Pharmaceuticals, an Amgen subsidiary, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sanofi Genzyme, Seattle Genetics, Sigma-Tau Pharmaceuticals Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro Inc, Teva Oncology and Tokai Pharmaceuticals Inc.

    RESEARCH TO PRACTICE STAFF AND EXTERNAL REVIEWERS — The scientific staff and reviewers for Research To Practice have no relevant conflicts of interest to disclose.

    This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

    This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company and Incyte Corporation.

    Hardware/Software Requirements:
    A high-speed Internet connection
    A monitor set to 1280 x 1024 pixels or more
    Internet Explorer 7 or later, Firefox 3.0 or later, Chrome, Safari 3.0 or later
    Adobe Flash Player 10.2 plug-in or later
    Adobe Acrobat Reader
    (Optional) Sound card and speakers for audio

    Last review date: July 2017
    Expiration date: July 2018

    After completing the Post-test, learners may download and review the answers here in order to identify further areas of study.

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