Dr Buchbinder on the Potential Role for RP1 Plus Nivolumab in Melanoma After PD-1 Progression
Source: OncLive, December 2024
Elizabeth Buchbinder, MD, assistant professor, Medicine, Harvard Medical School, senior physician, Medical Oncology, Dana-Farber Cancer Institute, discusses the potential implications of the FDA’s decision to grant breakthrough therapy designation to RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma.
In November 2024, a biologics license application (BLA) was submitted to the FDA for accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have previously received a regimen containing a PD-1 inhibitor. This combination concurrently received breakthrough therapy designation from the FDA for the same indication. Both the BLA submission and breakthrough designation are supported by data from the anti-PD-1–progressed melanoma cohort (n = 156) of the phase 1/2 IGNYTE trial (NCT03767348).
After a median follow-up of 15.4 months, the overall response rate (ORR) in this cohort was 32.7%, including complete response (CR) and partial response (PR) rates of 14.7% and 17.9%, respectively. Among patients who had previously received anti–PD-1 monotherapy (n = 82), the ORR was 37.8%, with CR and PR rates of 22.0% and 15.9%, respectively. In those previously treated with both PD-1 and CTLA-4 inhibitors (n = 74), the ORR was 27.0%, with CR and PR rates of 6.8% and 20.3%, respectively.