Dose Optimization in Oncology: How Do We Tackle the Tricky Topic of Combinations?

FDA’s Oncology Center of Excellence launched “Project Optimus” in 2021, to encourage sponsors to better optimize dose of new oncology agents. Project Optimus outlines expectations for dose optimization, and FDA has held workshops and published papers on how dose optimization should ideally proceed for novel single agents. However, none of these have addressed dose optimization for investigational therapies being studied in combination with other agents. Rather, the agency has acknowledged that this is a tricky area. This session will focus on approaches for dose optimization in combinations.