Accelerated Approval Sought for RP1-Nivolumab Combo for Pretreated Melanoma
Source: Oncology Nursing News, November 2024
The FDA received a biologics license application for the accelerated approval of RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) to treat adults with with advanced melanoma that was previously treated with a PD1 inhibitor.
The combination also received breakthrough therapy designation from the FDA for the same designation.
The breakthrough therapy designation was supported by safety and efficacy data from the anti-PD-1–failed melanoma cohort of the phase 1/2 IGNYTE trial (NCT03767348). Among all patients in this cohort (n = 156), at a median follow-up of 15.4 months (range, 0.5-55.5), the overall response rate (ORR) was 32.7%, including complete response (CR) and partial response rates of 14.7% and 17.9%, respectively.2 Among patients who had received prior anti–PD-1 monotherapy (n = 82), these respective rates were 37.8%, 22.0%, and 15.9%. Among those with prior exposure to both PD-1 and CTLA-4 inhibitors (n = 74), these respective rates were 27.0%, 6.8%, and 20.3%.