FDA advisory committee backs RP1 efficacy data in advanced melanoma, 10-3

Replimune Group announced on July 30, 2026 that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee met to discuss the company's Biologics License Application resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.¹

The committee discussed whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population, and the clinical meaningfulness of the response rate and duration of response reported in IGNYTE, including whether observed responses indicate systemic antitumor activity attributable to RP1.¹ The committee then voted 10 to 3 on the question of whether the efficacy results from IGNYTE are evaluable and clinically meaningful.¹

According to the company's presentation to the committee, the IGNYTE study reported an objective response rate of 33.6% (95% CI: 25.8, 42) and a duration of response of 24.8 months (95% CI: 14.1, NE), with adverse events mainly Grade 1 and 2 and no treatment-related Grade 5 events.² The presentation also noted that lifileucel (AMTAGVI) combined with an IL-2 regimen, approved in 2024 based on a single-arm trial in previously treated patients, showed an ORR of 31.5% in 73 patients with a 7.5% treatment-related mortality rate in a broader safety population of 160.²

Replimune CEO Sushil Patel said the company was encouraged by the outcome, calling it an important step forward for patients with advanced melanoma who have progressed on anti-PD-1 therapy, and said Replimune looks forward to continuing to work with the FDA as it completes its review of the BLA ahead of the action date.¹

The FDA's target action date under the Class 1 resubmission is August 2, 2026.¹