Replimune Presents 3-Year Landmark Overall Survival Analysis from IGNYTE Clinical Trial During Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting
Rhea-AI Summary
Replimune (NASDAQ: REPL) reported 3-year landmark overall survival data from the IGNYTE trial of RP1 plus nivolumab in anti–PD-1–failed advanced melanoma at the 2026 ASCO meeting.
Median overall survival reached 32.9 months; 3-year overall survival was 47.8% for all treated patients and 83.5% for responders. Objective response rate was 33.6% with a median duration of response of 24.8 months, and 44.8% of responders maintained responses at 3 years. A survival benefit was seen across key subgroups, with a predominantly Grade 1–2 safety profile and no Grade 5 events reported.
AI-generated analysis. Not financial advice.
Positive
- Median overall survival of 32.9 months in anti–PD-1–failed advanced melanoma
- At 3 years, 47.8% of all treated patients remained alive
- Three-year survival of 83.5% among responders to RP1 plus nivolumab
- Objective response rate of 33.6% with median response duration of 24.8 months
- Responses persisted at 3 years in 44.8% of responders
- Favorable safety profile with mainly Grade 1–2 events and no Grade 5 events
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus
REPL gained 85.68%, while key biotech peers showed modest mixed moves (e.g., BCYC +0.53%, CRVS -1.19%, NBTX -0.83%), pointing to a stock-specific reaction to the IGNYTE survival data rather than a sector-wide rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Oct 20 | BLA resubmission accepted | Positive | +98.8% | FDA acceptance of RP1 BLA resubmission with defined PDUFA action date. |
| Jan 08 | RP2 trials start | Positive | +3.0% | First patients enrolled in RP2 metastatic uveal melanoma and HCC trials. |
| Nov 09 | IGNYTE data at SITC | Positive | +0.5% | Primary IGNYTE analysis with 33.6% ORR and multi‑year survival data. |
| Sep 15 | IGNYTE at ESMO | Positive | -6.0% | Comprehensive IGNYTE efficacy and survival presentation at ESMO 2024. |
| Aug 22 | ESMO LBA selection | Positive | -1.3% | Late‑breaking IGNYTE abstract selected for oral presentation at ESMO. |
Clinical and regulatory milestones around RP1 have often produced strong moves, with some divergence where positive trial updates were met with flat or negative price reactions.
Over recent clinical milestones, Replimune has repeatedly highlighted RP1 plus nivolumab data in anti‑PD‑1‑failed melanoma. Events such as FDA acceptance of the RP1 BLA resubmission on Oct 20, 2025 and multiple IGNYTE data presentations at SITC 2024 and ESMO 2024 have shown consistent efficacy signals, including ORR around 33.6% and multi‑year survival rates. Price reactions have ranged from modest moves to a 98.78% gain, indicating that pivotal regulatory and high‑profile data disclosures can be major trading catalysts, providing context for the current 3‑year survival update.
Historical Comparison
Past clinical‑trial headlines for RP1/RP2 moved REPL an average of 18.98%. Today’s 85.68% move on 3‑year IGNYTE survival data stands out as a far larger reaction than prior trial updates.
Clinical disclosures have progressed from IGNYTE primary analyses and late‑breaking abstracts in 2024 to BLA resubmission acceptance in 2025 and now a 3‑year landmark overall survival analysis in 2026.
Regulatory & Risk Context
An effective S-3/A shelf filed on Nov 06, 2025 registers up to $250,000,000 in securities, including an at‑the‑market component of up to $100,000,000 in common stock, providing flexibility to raise capital over time. No usage is recorded in the provided data.
Market Pulse Summary
This announcement details mature 3‑year IGNYTE data for RP1 plus nivolumab, including a median overall survival of 32.9 months, 47.8% of all treated patients alive at 3 years, and an 83.5% 3‑year survival rate among responders, with no Grade 5 events reported. These results extend earlier primary analyses and add longer‑term durability context. Investors may track how these outcomes interact with ongoing regulatory discussions around RP1 and the company’s capacity to fund further development under its existing shelf registration.
Key Terms
overall survival medical
median overall survival medical
objective response rate medical
median duration of response medical
oncolytic immunotherapies medical
AI-generated analysis. Not financial advice.
WOBURN, Mass., May 30, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today presented 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 annual meeting.
“The overall survival analysis from IGNYTE shows that nearly half of all treated patients in the study were alive at three years, including
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 to83.5% 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.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about dthe status of the FDA review of our BLA for RP1 or potential approval of such BLA, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to the outcome of FDA’s review process, our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of a global pandemic and related public health issues and the ongoing political and military conflicts, including trade conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
