All Times EDT
Keywords: dose optimization, oncology
The recent FDA Project Optimus has profound impact on oncology drug development. Across industry, we have seen feedbacks from the agency request more dose finding studies for oncology drugs. It becomes an important topic for drug companies how to balance the development speed and rigor in terms of dose optimization. Oncology drugs have historically been given a pass because of the belief that “more is better,” dating back to the genesis of chemotherapy. However, it is no long necessary true for agents with new mechanisms of action and greater efficacy and different safety profiles than older drugs. For example, chronic, low grade toxic effects may be more relevant and interfere with prolonged administration, hinder adherence and therefore may result in disease progression. Therefore, looking at toxicity other than DLT (dose limiting toxicity) beyond short time DLT winding (typically one cycle) is important. For subsequent dose expansion or phase II study, more studies are proposed to evaluate multiple dose levels (or with control), and subsequent confirmatory will also be adapted depending on the outcome of earlier trials. In this presentation, we will share our experience in address these questions with innovative statistical methodology and its implementation consideration.