Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: A Workshop

When: July 16, 2018 - July 17, 2018 (8:00 AM Eastern)
Where: Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001

Topics Biomedical and Health Research, Diseases, Health Services, Coverage, and Access, Quality and Patient Safety
Activity: National Cancer Policy Forum
Board: Board on Health Care Services

Immune checkpoints are a critical component of the body’s immune system and the mechanisms by which cancer escapes immune detection. Checkpoint inhibitors, such as those that target programmed death receptor-1 and its ligand (PD-1 and PD-L1), have changed the standard of care for multiple types of cancer and also represent a majority share of new cancer drug applications to FDA.

However, challenges that impede optimal clinical development and use of checkpoint inhibitor therapies for cancer include 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. Opportunities for collaboration across industry, academia, and government in a precompetitive space could help advance this work.

The National Cancer Policy Forum will hold a public workshop on July 16-17, 2018 to examine the opportunities to improve the clinical development of immune checkpoint inhibitor therapies for cancer, including in the context of site-agnostic indications. Discussion will be focused on combination therapies that are built upon the backbone of anti-PD-1/PD-L1 strategies. The workshop will feature invited presentations and panel discussions on topics that may include the challenges and opportunities for improving: 

The development, validation, and standardization of biomarkers for patient selection. 
The assessment of safety and efficacy/clinical benefit in clinical trials. 
Innovations in clinical development programs for combination treatment strategies, such as approaches for prioritizing potential combinations (including multi-modal therapy), the role of preclinical modeling to identify promising combinations, and mechanisms for facilitating access to the best drug candidates for combination trials. 
Evidence requirements and decision making in drug development and regulatory evaluation for site-agnostic indications. 
Collaboration and information exchange among clinicians, researchers, and the pharmaceutical and diagnostic industries, including precompetitive collaboration, especially for the development of biomarkers predictive of immune-related toxicities and treatment response.

Confirmed Moderators, Speakers, and Panelists
Amy Abernethy, Flatiron Health
Christopher Boshoff, Pfizer
Lisa Butterfield, Society for Immunotherapy of Cancer
Roger Dansey, Merck
Adil Daud, UCSF Helen Diller Family Comprehensive Cancer Center
Roy Herbst, Yale Comprehensive Cancer Center
Ramy Ibrahim, Parker Institute for Cancer Immunotherapy
Benjamin Izar, Dana-Farber Cancer Institute
Elizabeth Jaffee, Johns Hopkins University School of Medicine
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
Naiyer Rizvi, Columbia University Medical Center
Richard L. Schilsky, American Society of Clinical Oncology
Margaret Shipp, Dana-Farber Cancer Institute
Ahmad Tarhini, Cleveland Clinic
Dan Theodorescu, University of Colorado Cancer Center
Arvin Yang, Bristol-Myers Squibb

Planning Committee Members

Roger Dansey (Co-Chair), Merck

Samir N. Khleif (Co-Chair), Georgetown University 

Amy Abernethy, Flatiron Health

Edward Benz, Jr., Dana-Farber Cancer Institute

Gideon Blumenthal, Food and Drug Administration

Christoffer 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, University of Colorado Denver  

George Weiner, University of Iowa

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