CE Information and Faculty Disclosures

• TARGET AUDIENCE
  This activity is intended for medical oncologists, hematologist-oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of various solid tumors and hematologic cancers.
  
  OVERVIEW OF ACTIVITY
  The past several years have seen an explosion in the emergence of new therapies with the potential to leverage the natural ability of the human body to attack and treat cancer. Known as immune-mediated therapies or cancer immunotherapies, these promising treatments are taking center stage at medical conferences and generating excitement all over the world. Early immune therapies approved by the FDA in the 1990s provided marginal response rates and unfortunately brought with them the possibility of significant toxicities, and investigators have sought to exploit different mechanistic aspects of immunologic functioning to produce greater therapeutic benefit. The newest and perhaps most exciting arena in this endeavor has been the development and assessment of immune-modulating antibodies, or checkpoint immune modulators. These agents are aimed to enhance natural immune responses or overcome tumor-induced immune tolerance rather than block oncogenic tumor growth pathways.
  
  Not surprisingly the introduction of immune checkpoint inhibitors, particularly anti-PD-1/PD-L1 antibodies, has created a multitude of uncertainties, important clinical questions and knowledge gaps awaiting resolution. Foremost among these is the simple question of why certain patients enjoy profound and long-lasting benefits from these agents and others with apparently the same disease experience no clinical effect. This conundrum has impelled scientists to examine the biologic underpinnings of malignant cells, human immune response mechanisms and the cell environment in an effort to discover biomarkers predictive of benefit, or lack thereof, from these agents. While researchers have begun to understand some potential biomarkers, these advances have in no way put the search to rest. Scientists and clinicians are investigating a wide variety of biologic, genomic and immunologic factors across a multitude of diseases and clinical situations. To date none of this work appears to be ready for prime time or immediately actionable in the clinic, but some of this knowledge appears to be quite prescient and its application in clinical trials may represent an optimal treatment approach for appropriate patients. This special CME activity aims to bridge the gap between research and patient care by presenting one-on-one discussions with leading oncology investigators as they review available immunotherapeutic approaches, current understanding of predictive biomarkers and promising ongoing research efforts.
  
  LEARNING OBJECTIVES

  • Appraise the rationale for and clinical data with approved anti-PD-1/PD-L1 antibodies in the treatment of 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 for patients with metastatic non-small cell lung cancer, melanoma and other cancers, and select appropriate individuals for PD-L1 assessment.
  • Appreciate the similarities and differences among diagnostic assays and scoring methodologies 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 or microsatellite instability and response to anti-PD-1 immune checkpoint inhibitors in gastrointestinal and other cancers, and develop related assessment strategies.
  • Recognize current investigational efforts to identify other potential biomarkers of response to checkpoint inhibition, and consider how they may be applied in future clinical practice.

  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
  CME credit is no longer available for this issue
  
  AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
  CME credit is no longer available for this issue
  
  HOW TO USE THIS CME ACTIVITY
  This CME activity consists of a video component.
  CME credit is no longer available for this issue
  
  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:
  
  Dung Le, MD
  Associate Professor of Oncology
  Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  Baltimore, Maryland
  
  Advisory Committee: Bristol-Myers Squibb Company, Merck; Contracted Research: Aduro Biotech, Bristol-Myers Squibb Company, Merck.
  
  Jason J Luke, MD
  Assistant Professor of Medicine
  The University of Chicago
  Chicago, Illinois
  
  Consulting Agreements: 7 Hills Pharma LLC, Actym Therapeutics Inc, Amgen Inc, Array BioPharma Inc, AstraZeneca Pharmaceuticals LP, Benevir Biopharm Inc, Bristol-Myers Squibb Company, Castle Biosciences Incorporated, Checkmate Pharmaceuticals, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, NewLink Genetics, Nimbus Therapeutics, Novartis, Palleon Pharmaceuticals, Syndax Pharmaceuticals Inc, Tempest Therapeutics; Clinical Trials: AbbVie Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celldex Therapeutics, Corvus Pharmaceuticals, Delcath Systems Inc, Five Prime Therapeutics Inc, Genentech BioOncology, Immunocore, Incyte Corporation, Intensity Therapeutics, MacroGenics Inc, MedImmune Inc, Merck, Novartis, Pharmacyclics LLC, an AbbVie Company, Tesaro Inc.
  
  Naiyer Rizvi, MD
  Professor of Medicine
  Director of Thoracic Oncology and Phase I Immunotherapeutics
  Price Chair in Clinical Translational Research
  Columbia University Medical Center
  New York, New York
  
  Advisory Committee: AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, EMD Serono Inc, Genentech BioOncology, GlaxoSmithKline, Janssen Biotech Inc, Lilly, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc.
  
  EDITOR — Dr 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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals 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, administered by Janssen Scientific Affairs LLC, 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, Pfizer Inc, 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 CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent 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 grantor.
  
  This activity is supported by an educational grant from Merck.
  
  Hardware/Software Requirements:
  A high-speed Internet connection
  A monitor set to 1280 x 1024 pixels or more
  Internet Explorer 11 or later, Firefox 56 or later, Chrome 61 or later, Safari 11 or later, Opera 48 or later
  Adobe Flash Player 27 plug-in or later
  Adobe Acrobat Reader
  (Optional) Sound card and speakers for audio
  
  Last review date: June 2018
  Expiration date: June 2019