FDA Receives BLA for RP1 and Nivolumab Combo in Advanced Melanoma
Source: Targeted Oncology, November 2024
The FDA has received a BLA submission seeking the accelerated approval of RP1 plus nivolumab for the potential treatment of adult patients with advanced melanoma who have received prior treatment with a regimen that contains a PD-1 inhibitor.
Safety and efficacy data from the anti-PD-1–failed melanoma cohort of the phase 1/2 IGNYTE trial support this BLA submission. Of the patients included in this cohort and at a median follow-up of 15.4 months (range, 0.5-55.5), the overall response rate (ORR) was 32.7%. This included complete response (CR) and partial response (PR) rates of 14.7% and 17.9%, respectively.
For the 82 patients who had received prior anti–PD-1 monotherapy, the ORR, CR, and PR rates were 37.8% 22.0%, and 15.9%. Further, the respective rates for patients with prior exposure to both PD-1 and CTLA-4 inhibitors (n = 74) were 27.0%, 6.8%, and 20.3%.