National Academies Press: OpenBook
« Previous: Appendix A: Statement of Task
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 63
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 64
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 65
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 66
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 67
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Page 68

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Appendix B Workshop Agenda JULY 16, 2018 7:30 am Registration 8:00 am Welcome from the National Cancer Policy Forum and Workshop Overview Roger Dansey, Seattle Genetics Samir N. Khleif, Georgetown University Planning Committee Co-Chairs 8:15 am Session 1: Overview of PD-1/PD-L1 Therapy and the Need for Combination Therapies Moderator: Roger Dansey, Seattle Genetics The State-of-the-Art of PD-1/PD-L1 Development and Clinical Use/Outcomes Ramy Ibrahim, Parker Institute for Cancer Immunotherapy Limits of Monotherapy, and the State of PD-1 and PD-L1 Combination Therapies in Clinical Trials Roy Herbst, Yale Cancer Center 63 PREPUBLICATION COPY—Uncorrected Proofs

64 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS Criteria for Selecting Preclinical Combinations and Combination Prioritization Strategies in Early-Stage Drug Development • Academic Perspectives Khleif, Georgetown University Samir N. Dan Theodorescu, Samuel Oschin Comprehensive Cancer Institute • Industry Perspectives Schmidt, Merck Emmett Chris Boshoff, Pfizer Inc. Panel Discussion 10:30 am Break 10:45 am  Session 2: The Role of Biomarkers in Developing PD-1/ PD-L1 Combinations  Moderator: David Rimm, Yale University School of Medicine Overview of Biomarker Development for Immune PD-1/PD-L1 Checkpoint Blockade Combinations David Rimm, Yale University School of Medicine Perspectives on Biomarkers for PD-1/PD-L1 Combination Therapies • Naiyer Rizvi, Columbia University Medical Center • Benjamin Izar, Dana-Farber Cancer Institute • Margaret Shipp, Dana-Farber Cancer Institute The Unique Challenges in Developing Biomarker- Driven, Site-Agnostic Therapies Richard L. Schilsky, American Society of Clinical Oncology The Microbiome in Cancer Immunotherapy Christian Jobin, University of Florida Panel Discussion 12:45 pm Lunch PREPUBLICATION COPY—Uncorrected Proofs

APPENDIX B 65 1:30 pm  Session 3: Clinical Trial Design for PD-1/PD-L1 Combination Therapies  Moderator: George Weiner, University of Iowa Holden Comprehensive Cancer Center Combination Trial Design Strategies Adil Daud, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center Master Protocols for Immunotherapy Combinations Ahmad Tarhini, Cleveland Clinic and Case Comprehensive Cancer Center Strategies for Incorporating Biomarkers in Clinical Trials for PD-1/PD-L1 Combination Therapies Lisa Butterfield, University of Pittsburgh and the Society for Immunotherapy of Cancer Appropriate Endpoints for Evaluating the Efficacy of PD-1/PD-L1 Combination Therapies Elizabeth Jaffee, Johns Hopkins University School of Medicine Panel Discussion Includes speakers and • Linda House, Cancer Support Community • Louise Perkins, Melanoma Research Alliance 3:25 pm Break 3:35 pm  Session 4: Regulatory Challenges with Developing PD-1/PD-L1 Combination Therapies Moderator: Roy Herbst, Yale Cancer Center Overview of Regulatory and Labeling Challenges with Developing Immune Checkpoint Blockade Combination Therapies Amy McKee, Food and Drug Administration PREPUBLICATION COPY—Uncorrected Proofs

66 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS Regulatory Requirements for Site-Agnostic Indications Steven Lemery, Food and Drug Administration Industry Perspectives • Daniel Chen, Genentech/Roche • Katrin Rupalla, Bristol-Myers Squibb Panel Discussion 5:30 pm Adjourn Day 1 JULY 17, 2018 7:30 am Registration 8:00 am  5: Precompetitive Data Sharing and Session Collaboration to Develop PD-1/PD-L1 Combinations Moderator: Martin Murphy, CEO Roundtable on Cancer  Overview of How Real-World Evidence, Data An Sharing, and Precompetitive Collaboration May Influence the Development of PD-1/PDL-1 Combination Therapies Amy Abernethy, Flatiron Health Sharing Data to Support Development, Validation, and Standardization of Biomarkers in Patient Selection Used in Immunotherapy Trials Gaurav Singal, Foundation Medicine Precompetitive Use of Algorithms to Predict Adverse Events Sean Khozin, Food and Drug Administration Panel Discussion 10:00 am Break PREPUBLICATION COPY—Uncorrected Proofs

APPENDIX B 67 10:15 am Session 6: Stakeholder Perspectives on the Path Forward  Moderator: Ramy Ibrahim, Parker Institute for Cancer Immunotherapy • Roger Dansey, Seattle Genetics • Roy Herbst, Yale Cancer Center • Una Hopkins, White Plains Hospital • Linda House, Cancer Support Community • Marc Theoret, Food and Drug Administration 11:30 am Workshop Wrap-Up 11:45 am Adjourn PREPUBLICATION COPY—Uncorrected Proofs

PREPUBLICATION COPY—Uncorrected Proofs

Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop Get This Book
×
Buy Paperback | $50.00
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these “checkpoint” proteins and thwart the immune system’s ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response.

To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16–17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  6. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  7. ×

    View our suggested citation for this chapter.

    « Back Next »
  8. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!