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Replimune Presents Initial RP1 Data from the ARTACUS Clinical Trial at the 2023 American Transplant Congress (ATC) Meeting
Single agent RP1 showed meaningful anti-tumor activity, with an overall response rate of 27.3% (all complete responses) in evaluable patients, with all
About this update from Replimune Group, Inc.
[{"type":"text","content":"Single agent RP1 showed meaningful anti-tumor activity, with an overall response rate of 27.3% (all complete responses) in evaluable patients, with all responses ongoing to date\nWOBURN, Mass., June 06, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced initial data from ARTACUS, a Phase 1/2 trial evaluating RP1 for the treatment of cutaneous malignancies in patients who have had a kidney, liver, heart, lung, and/or a hematopoietic cell transplant. This data from the ARTACUS trial will be presented at the ATC 2023 Meeting being held in San Diego. “Cutaneous cancer represents the most common post-transplant malignancy in highly immuno-compromised solid organ transplant patients. The challenge treating this high-risk population is that the use of anti-PD1 therapies can lead to organ transplant rejection in these patients,” said Robert Coffin, President and Chief Research & Development Officer of Replimune. “We are pleased with the interim data from the ARTACUS study that demonstrates a compelling overall response rate and complete response rate of 27.3% with strong durability to date that makes RP1 a potentially safe and effective treatment for these patients.” Initial results from the Phase 1b/2 ARTACUS study of RP1 oncolytic immunotherapy in solid organ and hematopoietic cell transplant recipients with advanced cutaneous malignancies ARTACUS is Replimune’s multicenter, open-label, 2-part Phase 1b/2 study evaluating RP1 for the treatment of locally advanced or metastatic cutaneous malignancies (to skin, soft tissue, or lymph nodes) in solid organ transplant recipients. This initial analysis includes kidney transplant recipients. This is the first clinical trial assessing single-agent RP1 in immunocompromised patients.No immune-mediated adverse events or evidence of allograft rejection were observed.RP1 monotherapy was well tolerated, and the safety profile was similar to non-immunocompromised patients with advanced skin cancers (IGNYTE study)RP1 monotherapy showed clear anti-tumor activity, with a preliminary overall response rate (ORR) for the 11 evaluable patients with cutaneous squamous cell carcinoma (N=10) and Merkel cell carcinoma (N=1) of 27.3%, with 3 patients (27.3%) ...