New Data With RP1 Plus Nivolumab in PD-1–Refractory Melanoma Build on Positive Findings

Source: OncLive, June 2024

The oncolytic immunotherapy RP1 in combination with nivolumab (Opdivo) displayed activity in patients with melanoma who failed prior anti–PD-1 treatment, according to updated findings from the phase 2 IGNYTE trial (NCT03767348).

Per independent central review, patients who received the combination (n = 140) achieved an objective response rate (ORR) of 33.6% by modified RECIST v1.1 criteria and 32.9% per RECIST v1.1. Moreover, the responses were durable; 100% of responses lasted more than 6 months and the median duration of response (DOR) was over 35 months.

“The overall strength of the IGNYTE data and safety profile further highlights the potential of RP1 in a difficult treatment setting with limited options for patients,” Sushil Patel, PhD, the chief executive officer of Replimune, said in a press release.1 “Based on these compelling results and recent FDA interactions, we are increasingly confident in our path forward. We have shared the results with the agency and plan to request a pre-BLA meeting, in advance of our intended BLA submission. With these data in hand, we are preparing for a commercial launch next year.”