In the wake of a surprise FDA advisory committee vote on Thursday, the third time could be the charm for RP1 (vusolimogene oderparepvec), a melanoma drug candidate that's already been rejected twice by the agency.
Despite doubts from agency reviewers, the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that the phase II IGNYTE study -- which tested the investigational oncolytic immunotherapy in combination with nivolumab (Opdivo) -- demonstrated "evaluable and clinically meaningful" efficacy results.
"This is more anecdote than evidence..., but I think overall there is some signal there and we should follow that signal," said John Carrino, MD, MPH, a radiologist at Weill Cornell Medicine in New York City.
Drugmaker Replimune is seeking an accelerated approval based on the findings from IGNYTE, which included patients with unresectable advanced melanoma who had already progressed on anti-PD-1 therapy. In the study, 33.6% responded to RP1 plus the PD-1 inhibitor nivolumab, including complete responses in 16.4%.
Hussein Tawbi, MD, PhD, a melanoma expert at the University of Texas MD Anderson Cancer Center in Houston, said that level of response came despite the patient population being one with a very low expectation of response to an immunotherapy.
