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Replimune Group’s RP1 Clinical Trial Falls Short

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Replimune Group, a clinical-stage biotechnology company, has announced that its clinical trial evaluating the efficacy of RP1 as a treatment for cutaneous squamous cell carcinoma did not meet its primary endpoints.

The trial, which compared RP1 in combination with cemiplimab to cemiplimab alone as the standard of care, showed no significant improvement in terms of complete response rate or overall response rate.

Although the combination of drugs did result in an increase in the duration of response, the data collected thus far are still considered immature. Further follow-up will be necessary to establish conclusive results. As such, the trial will continue as planned to assess additional factors such as duration of response, progression-free survival, and overall survival.

In contrast to this setback, Replimune Group had a more positive update regarding a separate trial of RP1 as a treatment for anti-PD1 failed non-melanoma skin cancer. The company stated that this trial adds to a growing body of evidence supporting the potential of RP1 in difficult-to-treat cancer settings.

However, as part of its strategic focus on near-term priority studies, Replimune Group has decided to discontinue the development of RP2 and RP3 intended for the treatment of squamous cell carcinoma of the head and neck and colorectal cancer, respectively.

Notably, the ongoing 2L hepatocellular carcinoma trial will continue exclusively with RP2, while the development of RP3 will be completely discontinued.

This portfolio reprioritization is expected to extend Replimune’s cash runway into early 2026, enabling the company to concentrate on its core objectives.

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