Immuno-Oncology Add-On Trials: More May Not Be Better, US FDA Cautions

03 Jun 2024

• By Michael McCaughan

Oncology developers should ensure clinical development plans involving early-stage trials adding on to perioperative treatment regimens will show that new therapies are adding benefit in each phase, Oncology Center of Excellence Director Richard Pazdur said.

immuno-oncology — It's not a principle that we have to repeat a mistake, Richard Pazdur said. • Source: Shutterstock

Oncology sponsors developing new add-on treatments in early-stage cancer settings should prepare for the US Food and Drug Administration to push them to design trials that can clearly demonstrate efficacy in each phase of treatment, i.e. neoadjuvant and adjuvant.

Key Takeaways

FDA is increasingly uncomfortable with the quality of evidence that has made checkpoint inhibitors the accepted treatment in both the neoadjuvant and adjuvant settings.

Oncology Center of Excellence Director Richard Pazdur delivered that message in closing remarks after a 9 May discussion of trial...