Thursday, Replimune Group Inc (NASDAQ:REPL) released topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma.
Bristol-Myers Squibb Co’s (NYSE:BMY) Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat several types of cancer.
The results show that one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO 2024. All responses lasted longer than 6 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, Ph.D., CEO of Replimune…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.”
The anti-PD1 failed melanoma cohort from the IGNYTE clinical trial includes 140 patients who received RP1 plus nivolumab after confirmed progression while being treated with at least 8 weeks of prior anti-PD1 therapy (+/- anti-CTLA-4).
The topline results show the overall response rate was 33.6% by modified RECIST 1.1 criteria, the primary endpoint defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA.
Responses from the baseline were highly durable, with all responses lasting more than six months and the median duration of response exceeding 35 months.
RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 constitutional-type side effects observed. There were no Grade 5 events.
Price Action: REPL shares are up 28.40% at $7.14 at the last check on Thursday.
