Published: Sunday, June 1, 2025 · 3:15 PM | Updated: Sunday, June 1, 2025 · 3:15 PM
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- Replimune’s RP1 plus nivolumab shows a 32.9% response rate in anti-PD1 failed melanoma patients.
- Higher response rates achieved with deep/visceral injections (40.9-42.9%) compared to superficial-only injections (29.8%).
- The treatment displayed robust systemic effects, reducing 93.6% of injected lesions and 79.0% of non-injected lesions.
Replimune Group, Inc. (REPL, Financial) presented promising new data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from the IGNYTE clinical trial, which assessed the combination of RP1 (vusolimogene oderparepvec) and nivolumab in melanoma patients resistant to previous anti-PD-1 therapies. The trial demonstrated an objective response rate (ORR) of 32.9% and a complete response rate of 15.0%, with landmark overall survival rates of 75.3% at one year, 63.3% at two years, and 54.8% at three years. Median overall survival has not yet been reached.
One of the key findings of the study was the significantly higher response rates seen with deep/visceral injections, measuring between 40.9% and 42.9%, compared to the 29.8% achieved with superficial-only injections. The systemic efficacy of the treatment was underscored by a 93.6% reduction in injected lesions and a 79.0% reduction in non-injected lesions, indicating a strong systemic anti-tumor response.
From a safety perspective, RP1 proved to be well-tolerated with manageable adverse events. Notably, injections directly into lung and liver lesions showed minimal risks, with no bleeding events reported after liver injections and low-grade pneumothorax events occurring after lung injections.
Furthermore, a biosafety analysis confirmed that RP1 can be safely managed with standard disinfection procedures, presenting minimal risk of transmission. These results highlight the potential of RP1 in enhancing systemic immune responses in patients who have exhausted existing treatment options.
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