All Times EDT
Keywords: Dose optimization
This presentation will discuss regulatory perspectives on dose optimization in oncology drug development. Historically, dose-finding trials of cytotoxic chemotherapies relied on identification of the maximum tolerated dose based on the assumption that higher doses provide greater efficacy. This assumption may not hold for newer drug classes, including molecularly targeted therapies. Poorly characterized dose and schedule may lead to selection of a dose that provides more toxicity without additional efficacy, severe toxicities that require a high rate of dose reductions, intolerable toxicities that lead to premature discontinuation and missed opportunity for continued benefit from the drug, and potentially persistent or irreversible toxicities that limit the options for receiving benefit of subsequent therapies—to name a few examples. This presentation will focus on different strategies of dose determination for oncology drugs that seek to optimize dose selection as well as enable a complete understanding of the relationship between drug exposure and clinical outcomes.