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FDA advisors split but majority find RP‑1 evidence evaluable and clinically meaningful
Summary
At an FDA advisory committee meeting on July 29, 2026, clinicians, patients, and company representatives debated the evidence for RP‑1 (visolimogene) plus nivolumab in PD‑1‑refractory melanoma; the committee voted 10–3 that IGNITE results were evaluable and clinically meaningful despite FDA reviewers’ methodological concerns.
The Cellular, Tissue and Gene Therapies Advisory Committee met July 29, 2026 to review BLA 125827 from Replimmune for visolimogene (RP‑1) administered with nivolumab for adult patients with unresectable advanced cutaneous melanoma who progressed on prior anti‑PD‑1 therapy. Chair Evan Snyder opened the meeting and read the committee charge.
FDA reviewers outlined five key concerns about the IGNITE single‑arm study: inconsistent application of RECIST 1.1, many responders who had all target lesions injected (limiting assessment of systemic effect), retreatment beyond progression, biopsy‑ or resection‑driven changes to response calls, and aspects of the independent review process that could introduce bias. As Katie Barnett (CBER) summarized, "The FDA review team concludes that overall the reported ORR and DOR are confounded and difficult to interpret." (Katie Barnett)
Replimmune presented lesion‑level analyses, preclinical data, and clinical vignettes arguing for a systemic immune effect and durable benefit: Costa Zenos reported an independent central‑review ORR of 33.6% with median DOR 24.8 months and said the lesion‑level analysis showed a similar effect in injected and non‑injected lesions. Patient speakers and multiple melanoma clinicians gave emotional testimony describing dramatic, durable responses and urged that the drug be made available while the ongoing phase‑3 confirmatory trial completes enrollment.
After extended discussion the committee voted the efficacy results from IGNITE were evaluable and clinically meaningful (yes 10, no 3). Several panelists who voted yes emphasized the durability and depth of response and the urgent unmet need for patients who have progressed on PD‑1 therapy; those who voted no cited interpretability problems stemming from study conduct and response adjudication. The advisory vote is nonbinding; FDA will consider the committee’s deliberations in its regulatory decision and has noted the ongoing randomized IGNITE‑3 study that may clarify contribution of effect.
