Discussant of the abstract on the ASTRUM-004 trial, Justin F. Gainor, MD, emphasized the significant, positive improvements in survival among patients randomly assigned to receive the PD-1 inhibitor serplulimab vs placebo. Dr. Gainor is Director of the Center for Thoracic Cancers Program, Director of Targeted Immunotherapy at Massachusetts General Hospital, and Associate Professor of Medicine at Harvard Medical School.

“This was a well-conducted, straightforward study that showed improvements in progression-free and overall survival,” said Dr. Gainor. “These results reaffirm that chemotherapy plus PD-1 inhibition is a standard of care for patients with advanced squamous cell, non–small cell lung cancer.”

Justin F. Gainor, MD

Rethinking Clinical Trial Designs

Dr. Gainor also raised concerns about global inequalities in access to PD-1 inhibitors. According to Dr. Gainor, the abundance of agents (more than 50) targeting the PD-1 axis in clinical development has led to substantial redundancy in clinical trials.

“The current unmet need is for improved access and cost, not necessarily more assets,” he explained. “As a multistakeholder community, we need to rethink clinical trial designs—for example, noninferiority designs where the control arms are also receiving established PD-1 inhibitors as well as regulatory thresholds such as establishing bioequivalence for certain classes of agents like PD-1 inhibitors.” 

DISCLOSURE: Dr. Gainor has served as a consultant to or received honoraria from Bristol Myers Squibb, Genentech/Roche, Takeda, Loxo/Lilly, Blueprint Medicine, Gilead Sciences, Moderna, AstraZeneca, Mariana Therapeutics, Mirati, Jounce, Merus Pharmacueticals, Nuvalent, Pfizer, Novocure, AI Proteins, Novartis, Merck, iTeos, Karyopharm, and Silverback Therapeutics; has received research support from Novartis, Genentech/Roche, and Takeda; has received institutional research support from Bristol Myers Squibb, AstraZeneca, Palleon, Tesaro, Moderna, Blueprint, Jounce, Array Biopharma, Merck, Adaptimmune, Novartis, and Alexo; has served on the advisory board and has equity in AI Proteins; and has an immediate family member who is an employee with equity at Ironwood Pharmaceuticals.