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Thursday, Replimune Group Inc 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 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 respon.
