Replimune said its melanoma treatment TUDRIQEV is now commercially available in the United States and reported progress in its clinical programs alongside its fiscal second-quarter results. The launch is the main near-term business update: the company says physicians have begun prescribing the drug and it has more than a year of inventory available.
The release text provided ends at the start of its financial highlights, before any figures appear. It therefore does not include the quarter’s revenue, expenses, cash balance or other financial metrics.
TUDRIQEV launch
- TUDRIQEV, the brand name for vusolimogene oderparepvec-wtpg, was previously known as RP1. It is being marketed with nivolumab for adults with advanced melanoma whose disease has progressed after treatment with a PD-1-blocking regimen.
- Patients began receiving the treatment on October 6. Replimune says more than 15 institutions have prescribed it, and leading melanoma centers have added it to their formularies and begun treating patients.
- The company has engaged with more than 70% of its first 200 priority accounts to establish treatment workflows. It says providers could order the drug for next-day delivery when it became available.
- Replimune reports having more than a year of inventory on hand, produced at its own manufacturing facility.
- The treatment’s label permits use without requiring patients to have first received BRAF-targeted treatment. It can be injected into superficial, deep and visceral tumors, including lesions in the lungs and liver, and patients may be treated again when clinically appropriate.
- Replimune says multiple payer policies have been published covering TUDRIQEV according to its label. The treatment is included in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation.
- The company’s global Phase 3 IGNYTE-3 study is actively enrolling patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies, or cannot receive anti-CTLA-4 treatment. It compares TUDRIQEV plus nivolumab with physicians’ choice of treatment. Overall survival is the primary endpoint; progression-free survival and overall response rate are key secondary endpoints.
Other clinical-program update
- Replimune said its registration-directed Phase 2/3 REVEAL study of RP2 in metastatic uveal melanoma is actively enrolling. The trial compares RP2 plus nivolumab with ipilimumab plus nivolumab.
- The study’s primary endpoints are overall survival and progression-free survival. Overall response rate and disease control rate are secondary endpoints.
What changes for investors
TUDRIQEV has moved from development into U.S. commercial availability, with early institutional prescribing and payer coverage reported by the company. Replimune also has a confirmatory Phase 3 study underway for the treatment, while its RP2 program remains in clinical testing. The available release text does not provide the financial results needed to assess the quarter’s revenue, spending or cash runway.