In partnership with RAPS this webinar provided an overview of FDA’s Project Optimus and its potential impacts on oncology drug development. The historical 3×3 Phase 1 study design to establish a Maximum Tolerated Dose (MTD) was developed for cytotoxic agents (eg, platins). Now, most new agents are immunotherapies and other biologics for which a more standard dose-finding Phase 1 study is more appropriate; however, the “standard” 3×3 design to establish MTD is still being used. Project Optimus is intended to address this discrepancy and drive more appropriate dose selection for new, and existing, oncology agents. We’ll discuss the immediate implications on Phase 1 dosing and design, as well as the potential implications for products already into Phase 2 and 3 of development, including modeling and simulation.
