Clinical TrialMay 31, 2026, 08:02 AM
Replimune RP2 Phase 1 Data Shows 19.1% ORR in Solid Tumors
AI Summary
Replimune presented final Phase 1 first-in-human data for its oncolytic immunotherapy RP2, alone and in combination with nivolumab, in patients with advanced solid tumors at ASCO 2026. The trial demonstrated an objective response rate (ORR) of 19.0% for RP2 monotherapy and 19.1% for RP2 in combination with nivolumab. Responses were durable, and the treatment was well tolerated with no unexpected toxicities, confirming its intended mechanism of action and systemic immune engagement.
Key Highlights
- RP2 monotherapy achieved an objective response rate (ORR) of 19.0% (4/21 evaluable patients).
- RP2 in combination with nivolumab achieved an ORR of 19.1% (9/47 evaluable patients).
- The disease control rate for RP2 in combination with nivolumab was 48.9%.
- Pooled ORR in uveal melanoma was 33.3%, with a randomized Phase 2/3 trial enrolling.
- Responses were durable, with median duration of response not reached for monotherapy and 22.1 months for combination.
- RP2 monotherapy and combination with nivolumab were well tolerated with no Grade 4 or 5 treatment-related adverse events.
- Translational analyses confirmed RP2 reprogrammed tumors to immune-inflamed and activated systemic immune response.
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