Satellite Symposium I

Surrogate Clinical Endpoints
Cancer Immunotherapy Trials
May 8, 2015   12:15 – 2:45 pm
Bethesda North Marriott Hotel · Bethesda, Maryland U.S.A.
Moderator: Axel Hoos, M.D., Ph.D., GlaxoSmithKline

The effect of cancer immunotherapies is on the immune system and not directly on the tumor. The kinetics of immunotherapy are characterized by a cellular immune response followed by potential changes in tumor burden or patient survival. To adequately investigate immunotherapies in clinical trials, a new development paradigm including reconsideration of established endpoints addressing this biology is needed. Over the last several years, several initiatives across the cancer immunotherapy community were facilitated by the Cancer Research Institute’s Cancer Immunotherapy Consortium. They systematically evolved an immunotherapy-focused clinical development paradigm and proposed to redefine trial endpoints. Altered statistical models are needed to describe the hazard ratios as a function of time, and differentiate them before and after separation of curves to improve planning of phase III trials. Taken together, these recommendations may improve our tools for cancer immunotherapy investigations.

This Symposium will be presented as an adjunct to the Accelerating Anticancer Agent Development and Validation Workshop on Friday, May 8. There is no cost to attend, but individuals are asked to register in advance so that appropriate accommodations can be made. Check the “Surrogate Clinical Endpoints for Cancer Immunotherapy Trials” on the online registration form. Box lunch will be provided.


  • Rationale for Adjusted Endpoints for Cancer Immunotherapy Trials
    Speaker: Axel Hoos, M.D., Ph.D., GlaxoSmithKline
  • Milestone Survival
    Speaker: TBA
  • PFS and irPFS
    Speaker: Eric Rubin, M.D., Merck Research Laboratories
  • Patterns of Response, irORR, ir DCR in Hematologic Malignancies
    Speaker: Philippe Armand, M.D., Ph.D., Harvard University
  • Patterns of Response, irORR, irDCR in Solid Tumors
    Speaker: Giovanni Melillo, M.D., AstraZeneca Pharmaceuticals
  • Panel Discussion

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