Replimune Presents Primary Analysis Data from IGNYTE - GlobeNewswire
IGNYTE trial data shows RP1 combined with nivolumab has a 33.6% overall response rate in anti-PD1 failed melanoma patients, with 15% complete response rate. Responses were observed in both injected and non-injected tumors, including visceral lesions, and were durable with a median duration of response of 21.6 months. The treatment was well-tolerated with mostly Grade 1-2 adverse events.
Reference News
IGNYTE data shows RP1 + nivolumab effective across subgroups, including prior anti-PD1/anti-CTLA-4 and primary resistance to anti-PD1, with 33.6% ORR by mRECIST and 15% complete response rate. Median duration of response was 21.6 months, and 85% of responses ongoing >1 year. RP1 + nivolumab well-tolerated with low Grade 3-4 events.
IGNYTE trial data shows RP1 combined with nivolumab has a 33.6% overall response rate in anti-PD1 failed melanoma patients, with 15% complete response rate. Responses were observed in both injected and non-injected tumors, including visceral lesions, and were durable with a median duration of response of 21.6 months. The treatment was well-tolerated with mostly Grade 1-2 adverse events.
Replimune presented IGNYTE trial data of RP1 plus nivolumab in anti-PD1 failed melanoma at ESMO 2024, showing an ORR of 33.6% by mRECIST, 15% complete response rate, and 27.6 months median duration of response. The treatment was well-tolerated with mostly Grade 1-2 adverse events, and Replimune plans to submit a BLA for RP1 in 2H 2024.
IGNYTE primary analysis data shows RP1 combined with nivolumab has clinically meaningful activity across all subgroups, including prior anti-PD1 and anti-CTLA-4 recipients and primary anti-PD1 resistance cases. Both injected and non-injected lesions responded similarly. ORR was 33.6% by mRECIST and 32.9% by RECIST 1.1, with a complete response rate of 15%. Median duration of response was 21.6 months from response initiation and 27.6 months from treatment initiation. RP1 plus nivolumab is well-tolerated with predominantly Grade 1-2 events.