Strong response rate for RP1 plus nivolumab in anti-PD1 failed melanoma

Shares of Replimune (Nasdaq: REPL) closed up nearly 28% at $7.11 on Thursday after the company shared data on its oncolytic virus RP1 (vusolimogene oderparepvec), in combination with Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), which achieved a one-third overall response rate (ORR) in patients with melanoma who failed prior anti-PD-1 treatment.

The results of the IGNYTE clinical trial by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at the America Society of Clinical Oncology (ASCO) 2024, with all responses lasting greater than six months from baseline.

“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,” said Sushil Patel, chief executive of Replimune. “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.”