The FDA has recently issued a complete response letter (CRL) for the biologics license application of vusolimogene oderparepvec (RP1) in combination with nivolumab (Opdivo) for the treatment of advanced melanoma in patients who have previously received a PD-1 inhibitor–containing regimen. The CRL highlighted concerns regarding the phase 1/2 IGNYTE trial, stating that it was not deemed as an adequate and well-controlled clinical investigation to support approval. The FDA also noted challenges in interpreting the data due to the heterogeneity of the patient population enrolled in the trial.
Despite no safety issues being identified, the CRL outlined key areas for improvement in the confirmatory trial study design. Replimune, the developer of RP1, has announced plans to request a Type A meeting with the FDA to discuss a potential path towards accelerated approval for the agent. Data from the IGNYTE trial revealed promising results, with patients achieving a confirmed overall response rate (ORR) of 33.6% per modified RECIST criteria. Sensitivity analysis further supported these findings, showing a confirmed ORR of 32.9%. The company remains optimistic about the future of RP1 plus nivolumab in the treatment of advanced melanoma, despite the recent setback.
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