Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma

Core Viewpoint - Replimune Group, Inc. announced that the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of RP1 in combination with nivolumab for advanced melanoma treatment, indicating that the application cannot be approved in its current form [1][2] Group 1: FDA Response - The CRL states that the IGNYTE trial is not considered an adequate and well-controlled clinical investigation providing substantial evidence of effectiveness [2] - The FDA highlighted issues related to the heterogeneity of the patient population and the confirmatory trial study design that need to be addressed [2] - Importantly, the CRL did not raise any safety issues regarding the application [2] Group 2: Company Response - The company plans to request a Type A meeting with the FDA, expecting it to be granted within 30 days, to discuss a path forward for accelerated approval of RP1 [3] - The CEO expressed surprise and disappointment regarding the FDA's decision, noting that the issues raised in the CRL were not previously mentioned during mid- and late-cycle reviews [4] - The company remains confident that RP1 in combination with nivolumab can provide substantial benefits to advanced melanoma patients [4] Group 3: Product Information - RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response [5] - The RPx platform aims to induce immunogenic cell death and alter the tumor microenvironment to promote a strong systemic immune response [6]