On July 20, 2017, The Food and Drug Administration (FDA), in co-sponsorship with the American Association for Cancer Research (AACR), is announcing a public workshop entitled “Oncology Dose Finding Workshop Part 3.
FDA and 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.
Objectives of the Workshop:
- To identify best practices regarding patient selection for immune-oncology combinations.
- To identify best practices regarding dose selection and optimization for IO combinations.
- To discuss the utility of biomarkers as pharmacodynamics endpoints to aid in dose optimization.
- To discuss how the expectation of the demonstration of the contribution of each agent has to a combination and strategies to isolate the effect of each individual agent.
- To discuss modeling and simulation approaches which take into account non-clinical data and data borrowed from other sources.
- To discuss novel trial endpoints to define patient benefit.
July 20, 2017
8 am - 4 pm
W Washington DC
515 15th Street NW
Washington, DC 20004
To register for this meeting, visit the American Association for Cancer Research website in the link below:
Registration will close on July 17, 2017.
Who Should Attend:
This workshop will be open to the public. The primary audience will include pharmaceutical scientists working with small molecule development from academia, industry, and government regulatory agencies, both domestic and international.