The stock of Replimune Group, Inc. (NASDAQ: REPL) had a significant upswing in performance after a thorough data analysis of trial results; it increased by 27.88% to $7.11. This spike in activity may be explained by the encouraging topline outcomes of the IGNYTE clinical trial, which assessed RP1 in conjunction with nivolumab for patients with melanoma that is resistant to anti-PD1.
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Promising Clinical Outcomes
Replimune (REPL) announced that an independent central review of the IGNYTE trial indicated that approximately one-third of patients treated with RP1 plus nivolumab exhibited a positive response. These findings surpass the investigator-assessed data presented at ASCO 2024, with all responses enduring beyond six months from the baseline.
The strength and safety profile of the IGNYTE data underscore the potential of RP1 in treating a challenging medical condition with limited alternatives. Buoyed by these compelling results and recent engagements with the FDA, Replimune is optimistic about its future course. The company has shared the findings with the FDA and plans to request a pre-BLA meeting, anticipating a BLA submission. With these results, Replimune is gearing up for a commercial launch in the coming year.
Detailed Trial Insights And Safety Profile
The IGNYTE clinical trial’s anti-PD1 refractory melanoma cohort included 140 patients who received RP1 plus nivolumab following confirmed progression despite at least eight weeks of prior anti-PD1 therapy. The primary analysis, conducted by an independent central review, commenced after a 12-month follow-up for all participants.
The topline data revealed an overall response rate of 33.6% according to modified RECIST 1.1 criteria, the primary endpoint defined in the protocol, and 32.9% by RECIST 1.1 criteria, as requested by the FDA. The durability of responses was notable, with all responses lasting more than six months and a median response duration exceeding 35 months. Replimune plans to present the full primary analysis data, including key secondary endpoint data and subgroups, at an upcoming medical congress.
