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 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.
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
