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FINDING CURES TOGETHER<sup>SM</sup>

​​FDA-AACR Regulatory Science and Policy Workshop 

FDA-AACR: Oncology Dose-finding Workshop Part III

Date: July 20, 2017 

View workshop slides.

Read the workshop report.

Read the transcripts: Session 1. Session 2. Session 3.

Watch the videos: Session 1. Session 2. Session 3.

Only slides from presenters who have given permission will be included. Some presenters have opted not to have their slides posted.

Given the recent history of approvals based on the results of early phase trials driven by extraordinary efficacy data, the incentive for conducting rigorous dose-finding trials may not be overtly apparent. However, the increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dosing regimens underscores the need for a more efficient process of dose selection in the early stages of study design.

The FDA and the AACR have successfully held Oncology Dose-finding Workshops in 2015 and 2016. Patient and dose selection of oncology drugs will be of critical importance, as recent approvals of immune checkpoint inhibitors (ICIs) and early, promising readouts from studies combining ICIs with chemotherapy, targeted therapy, and other immuno-oncology agents will put enormous pressures on the current clinical trial infrastructure of the U.S. and the international community. A recent article in The Cancer Letter reported that 803 clinical trials currently testing PD-1 and PD-L1 drugs had over 160,000 slots for adult patients. As more ICIs enter the market, additional trials will seek to combine these products with standard of care therapies, novel small molecules, targeted antibodies, and other biologic therapies such as vaccines and engineered T-cells. This year’s workshop will focus on approaches to combination therapy and best practices regarding patient and dose selection, biomarkers to aid in selection, and novel endpoints that can define patient benefit.

SESSION I:    Immuno-oncology (IO) Overview – Scope of the problem

SESSION II:    Key Translational and Design Questions for IO Agents

SESSION III:    Considerations for Dose Selection of IO Combination Products

See the agenda. Read the speaker bios.

Workshop Co-chairs:

  • AACR Chair: Elizabeth M. Jaffee, MD, AACR president-elect; deputy director, The Sidney Kimmel Comprehensive Cancer Center; professor, oncology and pathology, The Johns Hopkins University School of Medicine; active staff in oncology, The Johns Hopkins Hospital; associate director for translational research, co-director of gastrointestinal cancer and diseases program, and co-director of The Skip Viragh Center for Pancreatic Cancer Research and Patient Care, The Sidney Kimmel Comprehensive Cancer Center; medical director, Johns Hopkins Oncology Center, Cell Processing and Gene Therapy Facility, and faculty, Graduate Programs in Immunology, Cellular and Molecular Medicine, and Pharmacology, The Johns Hopkins University School of Medicine
  • FDA Chair: Amy E. McKee, MD, supervisory associate director, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA