Replimune Group, Inc. announced results from the primary analysis of the CERPASS trial evaluating RP1 in combination with cemiplimab for the treatment of locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) and provided initial data for all patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. The CERPASS clinical trial was a global, randomized study enrolling 211 patients randomized 2 to 1 to receive RP1 plus cemiplimab versus cemiplimab standard of care for patients with locally advanced or metastatic CSCC. The CERPASS study was conducted under a Master Clinical Trial Collaboration and Supply Agreement with Regeneron Pharmaceuticals.

IGNYTE Regulatory Update: The company recently participated in a Type C meeting with the U.S. Food and Drug Administration (FDA). During the discussion, the FDA acknowledged that the anti-PD1 failure melanoma population is one of unmet need. The FDA agreed with an anti-PD1 failed melanomas confirmatory study design concept consisting of a 2-arm randomized trial with physician's choice of treatment as a comparator arm in the study population.

As previously presented, treatment with RP1 monotherapy in the Phase 1/2 ARTACUS clinical trial in skin cancer patients who have had solid organ or hematopoietic cell transplants led to an ORR of 34.8% (8 of 23 evaluable patients, including 5 CRs and 3 partial responses). Portfolio Update: As previously shared, the company presented strong data with RP2 in uveal melanoma during a plenary session at the 20th International Congress of the Society for Melanoma Research in November. Based on the data in this population, planning is underway for a randomized controlled clinical trial of RP2 in second line (2L) uveal melanoma with the company intending to investigate other rare cancer opportunities as target indications.