Replimune Presents Late-Breaking Abstract Featuring Data from IGNYTE Clinical Trial of RP1 Combined with Nivolumab in Anti-PD1 Failed Melanoma at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024)

Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics

Initial biomarker data shows increase in tumor CD8+ T cell and PD-L1 expression after dosing along with an increase in gene signatures associated with CD8+ T cells and inflammatory cytokines, highlighting the potential of RP1 plus nivolumab to generate a potent anti-tumor immune response

WOBURN, Mass., Nov. 09, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the primary analysis data from the IGNYTE clinical trial, including initial biomarker analyses, was presented as a late-breaking abstract during an oral session at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024) in Houston, Texas. In addition, data from the ARTACUS clinical trial evaluating RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies was also shared in an encore poster presentation during the meeting.

“The initial biomarker analyses included in the SITC presentation which demonstrate increases in tumor CD8+ T cell infiltration and PD-L1 expression along with the induction of an immune inflammatory gene signature after treatment, further support the intended mechanism of RP1 in combination with nivolumab, including its ability to induce a systemic response after progression on prior anti-PD1 therapy,” said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. “We believe that the systemic activity of RP1 and nivolumab is in particular demonstrated by the similar level of responses seen in both injected and non-injected lesions, including hard to treat visceral lesions, and by the durability of the responses seen.”

IGNYTE Clinical Trial Data at SITC
The IGNYTE clinical trial cohort in anti-PD-1 failed melanoma included 140 patients who received RP1 plus nivolumab after confirmed progression while being treated for at least 8 weeks with anti-PD-1 based therapy, with or without anti-CTLA-4. The primary analysis by blinded independent central review was triggered once all patients had been followed for at least 12 months. The median follow-up at the time of the primary analysis was 15.4 months (0.5-47.6 months).