All Times EDT
Keywords: Dose finding, Dose optimization, oncology
“It may be time to start applying the brakes to oncology drug development”, this is the opinion of the US FDA’s Oncology Center of Excellence quoted by Pink Sheet article on Aug 13, 2021. After nearly 10 years of thinking about how to determine the best dose for investigational oncology drugs, the FDA is getting serious about requiring sponsors to conduct dose-finding studies early. In a perspective article recently published in The New England Journal of Medicine entitled “The Drug-Dosing Conundrum in Oncology – When Less Is More”, authors from the FDA argue for the need to re-examine the “more is better” paradigm in dose selection for oncology drugs. Friends of Cancer Research is calling on all stakeholders to start to incorporate dose-finding early in clinical development. Dose optimization in oncology drug development is the focus of a new white paper that the group released at its 2021 annual meeting. In oncology, it has been a long-time common practice to select the maximum tolerated dose (MTD) as the dose to be carried forward in late-phase clinical trials, until now. The thinking that higher drug doses would be associated with greater efficacy dates to the development of cytotoxic agents. With the new molecular target agents and immunotherapies, a higher dose does not necessarily result in improved antitumor activity. The tendency to continue using the MTD may be driven by a desire for efficient development to fulfill unmet need as identifying an optimal dose takes more exploration. Is it possible to achieve both the efficiency and dose optimization at the same time? This session is organized to discuss the impact of the new directive from FDA on oncology early development by focusing on the key considerations for dose optimization strategies, dose-finding study designs and methodology in oncology drug development. Speakers from industry, academia and regulatory agencies will present recommendation, examples and lessons learned from their perspectives.