Nivolumab

Oct. 19, 2025 -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab was presented by Caroline Robert, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) Congress 2025 being held in Berlin (Poster 1644P) The analysis of acral melanoma patients from the IGNYTE clinical trial showed treatment with RP1 combined with nivolumab resulted in an objective response rate of 44% (8/18) with a median duration of response of 11.9 months (3.9, not reached). The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events. Acral melanoma is a rare and aggressive type of cutaneous melanoma (2-3% of all melanoma cases) that frequently occurs on the palms of the hands, soles of the feet, and nailbeds, and often has poor outcomes with many patients presenting with in-transit metastases. Acral melanoma does not typically respond well to available therapies, such as immune checkpoint inhibitors. Following progression on first-line therapy, aside from targeted therapy for a subset of patients with BRAF mutation-positive tumors, few viable treatment options exist. The IGNYTE-3 randomized controlled phase 3 trial evaluating RP1 plus nivolumab versus physician’s choice of treatment in melanoma that has progressed on anti-PD1 and anti-CTLA-4 therapy is currently recruiting. An additional poster titled, “Efficacy and safety of RP1 + nivolumab in patients with non-melanoma skin cancers (NMSC)” is also being presented at ESMO by Dirk Schadendorf, M.D. (Poster 1661P). The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (≤10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated. 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. 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. The content above comes from the network. if any infringement, please contact us to modify.