On May 30, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.
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"The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including 83.5% of responders to RP1 plus nivolumab," said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. "This represents a durable benefit that is rarely seen in anti-PD-1-failed melanoma, a setting with historically limited treatment options."
Key findings are detailed below.
Oral Presentation: A 3-year landmark overall survival analysis of RP1 plus nivolumab in patients with anti-PD-1-failed melanoma from the IGNYTE clinical trial; Date/Time: May 30, 2026, 5:30 PM CDT; Location: E451; Abstract: 9518; Presenter: Michael Wong, MD, PhD
RP1 (vusolimogene oderparepvec) plus nivolumab achieved a median overall survival (mOS) of 32.9 months in patients with anti–PD-1–failed advanced melanoma, a population with limited treatment options.
At 3 years, 47.8% of all treated patients remained alive, rising to 83.5% among responders, underscoring the depth and durability of the treatment’s benefit.
The objective response rate (ORR) was 33.6%, with a median duration of response (DOR) of 24.8 months; 44.8% of responders maintained their response at 3 years.
Meaningful survival benefit was observed across all key patient subgroups, including those with varying disease stage, PD-L1 expression status, prior anti–CTLA-4 therapy, and primary or secondary anti–PD-1 resistance.
The combination continued to demonstrate a favorable and manageable safety profile over long-term follow-up, with predominantly Grade 1–2 constitutional side effects, no Grade 5 events, and no new safety signals identified.
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
(Press release, Replimune, MAY 30, 2026, View Source [SID1234666250])