Preliminary ARTACUS Trial Data on RP1 Solo Treatment for Skin Cancer in Transplant Patients Showcased at AACR 2024
Replimune Group, a biotech firm specializing in oncolytic immunotherapies, has reported promising interim findings from the ARTACUS Phase 1/2 clinical trial. The study, which focuses on the use of RP1 monotherapy for skin cancer treatment in transplant patients, was detailed at the AACR 2024 Annual Meeting by Dr. Michael R. Midgen from the University of Texas MD Anderson Cancer Center.
RP1 monotherapy, administered up to 25 times, demonstrated an overall response rate of 34.8% among 23 evaluable patients. This included five complete responses and three partial responses, with most responses still ongoing as of September 18, 2023. The patient group comprised 20 with cutaneous squamous cell carcinoma and three with merkel cell carcinoma.
Notably, a CSCC patient also experienced a complete response in a new primary basal cell carcinoma that emerged after the baseline. The treatment showed no signs of allograft rejection and was well-tolerated, with a safety profile akin to that of non-immunocompromised patients with advanced skin cancers. Post-treatment biomarker analysis indicated an increase in CD+8 T cells and PD-L1 expression, pointing to immune system activation. Dr. Sushil Patel, CEO of Replimune, highlighted the higher risk of skin cancer in organ transplant recipients and the limited treatment options available due to systemic immunotherapy contraindications.
The data suggest that RP1 monotherapy could be a safe and effective alternative, with a nearly 35% overall response rate and sustained benefits. The ARTACUS trial is a multicenter, open-label study assessing the safety and tumor-reducing capabilities of RP1 monotherapy in patients with locally advanced or metastatic cutaneous malignancies who have undergone organ or hematopoietic cell transplantation and are on chronic immunosuppressive treatment. The trial is actively recruiting participants. RP1, Replimune's lead candidate, is a modified herpes simplex virus designed to enhance tumor destruction and stimulate a systemic anti-tumor immune response. Replimune, founded in 2015 and based in Woburn, MA, aims to revolutionize cancer treatment with its innovative oncolytic immunotherapy portfolio.
The company's RPx platform is engineered for potent immunogenic cell death and systemic immune response induction, with potential synergies with various cancer treatments. The press release includes forward-looking statements regarding the clinical trial design, product candidate development, and potential regulatory approvals, which are subject to risks and uncertainties that could significantly affect actual outcomes. Replimune's actual results may vary materially from the forward-looking statements due to factors such as operating history limitations, clinical trial results, regulatory changes, competitive challenges, and global health issues like the coronavirus pandemic.
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