Replimune Group, Inc. (NASDAQ: REPL) announced that the U.S. Food and Drug Administration has granted accelerated approval for Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.

The approval is based on objective response rate and duration of response data from the IGNYTE trial. Continued approval may be contingent on verification of clinical benefit in a confirmatory trial.

The IGNYTE trial enrolled 140 patients, with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In that group, Tudriqev combined with nivolumab achieved an objective response rate of 24.2% and a median duration of response of 14.1 months. The patient population included those with Stage 4 disease (80%), PD-L1 negative status (54%), and liver lesions (24%).

Serious adverse reactions occurred in 35% of the 140 patients treated with the combination. The most common adverse reactions, occurring in more than 10% of patients, included fatigue, pyrexia, chills, nausea, and musculoskeletal pain. There were no grade 4 or 5 common adverse events. Adverse reactions leading to permanent discontinuation of Tudriqev occurred in 2.9% of patients.

Tudriqev is administered via direct intratumoral injection into superficial and deep or visceral lesions, with imaging guidance used for deep or visceral tumors. Dosing is based on tumor size.

A confirmatory Phase 3 trial, IGNYTE-3, is ongoing to verify the clinical benefit of Tudriqev in combination with nivolumab.

According to the press release, melanoma accounts for approximately 8,500 deaths annually in the U.S., and roughly half of patients do not respond to or progress after treatment with immune checkpoint inhibitors.