Uncategorised VJToday

FDA approves vusolimogene oderparepvec plus nivolumab for advanced melanoma

On August 6, the U.S. Food and Drug Administration (FDA) approved vusolimogene oderparepvec (RP1), an HSV-1-based oncolytic immunotherapy expressing granulocyte macrophage colony-stimulating factor (GM-CSF) and a fusogenic protein (GALV-GP R-), in combination with nivolumab for the treatment of patients with advanced melanoma previously treated with anti-PD-1 therapy.1 Treatment options for patients who progress on anti-PD-1 therapy remain limited, often associated with high toxicity and low efficacy. RP1 addresses this unmet need by delivering durable antitumor responses with a favorable safety profile.

The approval is based on findings from the IGNYTE clinical trial (NCT03767348), which demonstrated robust and durable responses in patients with advanced melanoma who had progressed on prior anti-PD-1-containing regimens, including those with previous anti-CTLA-4 exposure. The confirmed overall response rate (ORR) by independent central review was 33.6% (95% CI: 25.8, 42.0) with a 15.0% complete response rate. The median duration of response (DOR) was 33.7 months (95% CI, 14.5, NR). Responses occurred in both injected and non-injected visceral lesions.2

Gino In, MD, MPH, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, highlights the significance of the trial, stating that:

“With RP1 combining with nivo, we have seen more of an abscopal effect. We’ve seen better responses with patients who were treated in the refractory setting and then also we’ve been able to inject visceral lesions and done that safely, so it does seem like it’s maybe a more effective therapy and probably one that may change the treatment landscape.”

This approval marks a significant advancement for patients with anti-PD-1-resistant melanoma. The ongoing Phase III IGNYTE-3 trial (NCT06264180) is expected to further validate the efficacy and safety of RP1 in combination with nivolumab in this difficult-to-treat population.

References:

  1. Center for Drug Evaluation and Research. FDA approves Vusolimogene Oderparepvec Plus Nivolumab for Advanced Melanoma, [Internet]. FDA; [cited 2026 Aug 07]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
  2. Wong MK, Milhem MM, Sacco JJ, Michels J, In GK, Muñoz Couselo E, et al. RP1 combined with nivolumab in advanced anti–PD-1–failed melanoma (IGNYTE). Journal of Clinical Oncology. 2025 Nov 20;43(33):3589–99. doi:10.1200/jco-25-01346