Replimune has won FDA accelerated approval for Tudriqev, its oncolytic immunotherapy formerly known as RP1, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that has progressed after an anti-PD-1-based treatment regimen. The decision gives patients with treatment-resistant disease a new option following a regulatory process in which the therapy had previously been rejected twice.
Tudriqev, or vusolimogene oderparepvec-wtpg, is a genetically modified herpes simplex virus designed to preferentially replicate in tumors, destroy cancer cells and promote an anti-tumor immune response. It is administered by direct injection into superficial, deep or visceral tumors, with image guidance used for deep or visceral lesions.
Approval was based on the Phase 1/2 IGNYTE study, which enrolled 140 patients with advanced melanoma whose disease had progressed while receiving anti-PD-1 therapy. Among 91 efficacy-evaluable patients with at least one non-injected lesion, the Tudriqev-nivolumab combination produced an objective response rate of 24.2%, with a median response duration of 14.1 months.
The approval comes after a turbulent review. FDA staff had challenged the trial’s design and response assessments, but an agency advisory panel supported the treatment, citing the need for options in a difficult-to-treat population. Replimune had argued after a prior rejection in April that an earlier FDA review team considered its evidence adequate to demonstrate the treatment’s benefits.
Accelerated approval means Replimune must verify clinical benefit in a confirmatory trial for the therapy to remain on the market. The company’s ongoing Phase 3 IGNYTE-3 trial is evaluating Tudriqev plus nivolumab in this patient population.
Replimune said common adverse reactions included fatigue, fever, chills, musculoskeletal pain, nausea, diarrhea or colitis, injection-site reactions, headache and cough.
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