Replimune Group announces initial data from IGNYTE trial on RP1

Replimune Group announced an initial data snapshot from the first 75 patients from the anti-PD1 failed cutaneous melanoma cohort of the IGNYTE clinical. Data Snapshot from the IGNYTE Clinical Trial Evaluating RP1 Combined with Nivolumab in anti-PD1 Failed Melanoma: IGNYTE is Replimune’s multi-cohort clinical trial evaluating RP1 combined with nivolumab in multiple tumor type specific cohorts. The ORR in the first 75 patients from the anti-PD1 failed melanoma cohort was 36%, consistent with that observed in the prior Phase 2 cohort presented in June 2022 where an ORR of 37.5% was seen. The complete response rate was 20.0%, compared to 12.5% shown in the prior 16 patients presented in June 2022. The data clearly demonstrate systemic activity, with both injected and in un-injected lesions responding, including in un-injected visceral disease. Most responses seen were in patients who did not respond to prior anti-PD1 therapy. Safety data with RP1 in combination with nivolumab assessed across all skin cancer patients treated with RP1 combined with nivolumab, including the new 75 patients, continues to demonstrate an attractive safety profile, with predominantly ‘on target’ Grade 1-2 side effects indicative of systemic immune activation. Overall, Replimune believes that RP1 in combination with nivolumab has the potential to become a go-to treatment option for melanoma patients after progressing on or after anti-PD1 therapy, including on adjuvant therapy or on or after a first- or second-line anti-PD1-containing regimen, including in combination with anti-CTLA-4.