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Replimune Provides RP1 Data Update from its Phase 2 Cohorts in Melanoma and Non-Melanoma Skin Cancer that Strongly Support Replimune’s Ongoing Registration-Directed Clinical Trials with RP1
Multiple Complete Responses Observed in Advanced Cutaneous Squamous Cell Carcinoma High Rate of Deep Responses in Anti-PD-1 / Anti-CTLA-4 Refractory Melanoma
About this update from Replimune Group, Inc.
[{"type":"text","content":"Multiple Complete Responses Observed in Advanced Cutaneous Squamous Cell Carcinoma\n High Rate of Deep Responses in Anti-PD-1 / Anti-CTLA-4 Refractory Melanoma Announces Intention to Commence Clinical Development in Anti-PD-1 Refractory Non-Small Cell Lung Cancer WOBURN, Mass., June 03, 2020 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced new interim data presented from the Phase 2 part of its Phase 1/2 clinical trial of RP1 in combination with Opdivo® that continues to provide strong support for its lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD-1 refractory melanoma. “CSCC is a significant commercial opportunity that we believe has the potential to drive substantial value for the company. The number of complete responses (CRs) observed is highly suggestive that our combination approach with RP1 can provide better patient outcomes compared to anti-PD-1 therapy alone, where CRs are infrequent,” said Philip Astley-Sparke, CEO of Replimune. “In anti-PD-1 refractory melanoma, we believe we also have a strong efficacy signal and are optimistic that our currently-enrolling 125 patient cohort could generate data to support regulatory approval, pending feedback from the U.S. Food and Drug Administration (FDA) and other regulatory agencies. We are also excited to be moving to evaluate RP1 in anti-PD-1 refractory non-small cell lung cancer (NSCLC), given the large unmet need in this tumor type. We believe we have established clinical proof of principle with RP1 in immune-responsive tumor types and in anti-PD-1 refractory cancers, and now have a solid foundation upon which to establish our product candidates more broadly as the second cornerstone of immuno-oncology.” New interim clinical data in CSCC from the enrolling 30 patient non-melanoma skin cancer cohort evaluating RP1 in combination with Opdivo continues to strongly support the Company’s registration-directed clinical trial of RP1 in combination with Libtayo® Overall, four of seven evaluable patients have ongoing CRs and six of seven have an ongoing CR or partial response (PR) (compared to one out of five patients and two out of five, respectively, as presented at the Society for the Immunotherapy of Cancer meeting in November...