Immune checkpoint inhibitors, such as those that target PD-1 and PD-L1 proteins, have changed the standard of care for multiple types of cancer and also represent a majority share of new cancer drug applications to FDA. Recently, there has been growing interest in combining checkpoint inhibitors with other therapies to further improve efficacy. However, several challenges impede optimal clinical development of combination therapies with checkpoint inhibitors, such as prioritizing combinations for testing, identifying patients who are most likely to benefit, assessing endpoints for safety and clinical benefit, overcoming resistance to therapy, and developing cancer site-agnostic indications.
The National Cancer Policy Forum held a public workshop on July 16-17, 2018 to examine the opportunities to improve the clinical development of combination cancer therapies that include immune checkpoint inhibitors. The workshop convened patient advocates and representatives from industry, academia, and government to discuss topics that included:
• an overview of PD-1/PD-L1 therapy and the need for combinations
• the role of biomarkers in developing PD-1/PD-L1 combinations
• clinical trial design strategies and considerations
• regulatory challenges and opportunities
• precompetitive data sharing and collaboration
Confirmed Moderators, Speakers, and Panelists
Amy Abernethy, Flatiron Health
Chris Boshoff, Pfizer
Lisa Butterfield, Society for Immunotherapy of Cancer
Daniel Chen, Genentech/Roche
Roger Dansey, Seattle Genetics, Inc.
Adil Daud, UCSF Helen Diller Family Comprehensive Cancer Center
Roy Herbst, Yale Cancer Center
Una Hopkins, White Plains Hospital
Linda House, Cancer Support Community
Ramy Ibrahim, Parker Institute for Cancer Immunotherapy
Benjamin Izar, Dana-Farber Cancer Institute
Elizabeth Jaffee, Johns Hopkins University School of Medicine
Christian Jobin, University of Florida
Samir N. Khleif, Georgetown University
Sean Khozin, Food and Drug Administration
Steven Lemery, Food and Drug Administration
Amy McKee, Food and Drug Administration
Martin Murphy, CEO Roundtable on Cancer
Louise Perkins, Melanoma Research Alliance
David Rimm, Yale University School of Medicine
Naiyer Rizvi, Columbia University Medical Center
Katrin Rupalla, Bristol-Myers Squibb
Richard L. Schilsky, American Society of Clinical Oncology
Emmett Schmidt, Merck
Margaret Shipp, Dana-Farber Cancer Institute
Gaurav Singal, Foundation Medicine
Ahmad Tarhini, Cleveland Clinic and Case Comprehensive Cancer Center
Dan Theodorescu, Samuel Oschin Comprehensive Cancer Institute at Cedars Sinai
Marc Theoret, Food and Drug Administration
George Weiner, University of Iowa Holden Comprehensive Cancer Center
Planning Committee Members
Roger Dansey (Co-Chair), Seattle Genetics, Inc.
Samir N. Khleif (Co-Chair), Georgetown University
Amy Abernethy, Flatiron Health
Edward Benz, Jr., Dana-Farber Cancer Institute
Gideon Blumenthal, Food and Drug Administration
Chris Boshoff, Pfizer
Otis Brawley, American Cancer Society
Christopher Cogle, University of Florida
Lisa Kennedy Sheldon, Oncology Nursing Society
Lee Krug, Bristol-Myers Squibb
Martin Murphy, CEO Roundtable on Cancer
David Reese, Amgen, Inc.
Richard L. Schilsky, American Society of Clinical Oncology
Dan Theodorescu, Samuel Oschin Comprehensive Cancer Institute at Cedars Sinai
George Weiner, University of Iowa Holden Comprehensive Cancer Center
To view videos of this event, please visit:
https://www.youtube.com/playlist?list=PLGTMA6QkejfgvKGnbCSBmC-X245nXV0oh