Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced that TUDRIQEV™ (vusolimogene oderparepvec-wtpg) is now commercially available in the United States. TUDRIQEV is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

TUDRIQEV received accelerated approval from the U.S. Food and Drug Administration in early August. Beginning today, healthcare providers can order TUDRIQEV for next day delivery.

"With TUDRIQEV now available, we have reached a critical milestone in bringing this therapy to patients with advanced melanoma who have been waiting for a new option," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "I'm deeply proud of our team, who moved with urgency to put the infrastructure and comprehensive patient support services in place so that healthcare providers can access this therapy with next day delivery when their patients need it.”

Administration
TUDRIQEV is administered by direct intratumor injection into superficial, deep, and/or visceral lesions, with imaging guidance used for deep or visceral lesions. It is given once every two weeks for eight consecutive doses, with the dose based on tumor size; a lower concentration is used for the first dose and a higher concentration for subsequent doses. Nivolumab is administered intravenously beginning at week three. Please see the full Prescribing Information for complete dosing, preparation, handling, and administration instructions.

Clinical Data Supporting Approval
The accelerated approval was based on the registrational anti-PD-1-failed melanoma cohort of the IGNYTE trial, which enrolled 140 patients. Among the 91 efficacy-evaluable patients with at least one non-injected lesion, TUDRIQEV plus nivolumab achieved an objective response rate of 24.2% (95% CI: 15.8, 34.3) with a median duration of response of 14.1 months (95% CI: 10.7, not reached).

A confirmatory Phase 3 trial, IGNYTE-3 (NCT06264180), is ongoing.

ReplimuneConnect Plus Patient Support Program
Replimune is committed to helping eligible patients in the U.S. access treatment with TUDRIQEV. ReplimuneConnect Plus is a comprehensive program that provides information and support on access, reimbursement, and financial assistance for eligible patients who are prescribed TUDRIQEV, including benefits investigation, co-pay assistance for eligible commercially insured patients, referrals to independent foundations, and case manager support.