Accelerated Approval Sought for RP1 Plus Nivolumab in Advanced Melanoma
Source: OncLive, November 2024
A biologics license application was submitted to the FDA seeking the accelerated approval of RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have received prior treatment with a regimen containing 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%.
“Today is an important milestone for Replimune and for the melanoma community as we are 1 step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD-1–containing regimens,” Sushil Patel, PhD, CEO of Replimune, stated in a news release.