Purpose: 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. 

Theme:   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.

Who Should Attend:  This workshop will be open to the public. The primary audience will include pharmaceutical scientists working with small molecule development whether from academia, industry, or government regulatory agencies

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