Replimune Group presents interim results from ARTACUS trial of RP1 monotherapy

Replimune Group announced the presentation of interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants at the AACR 2024 Annual Meeting in San Diego. The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer. In the study, treatment with RP1 as monotherapy, for up to 25 doses, resulted in an overall response rate of 34.8% with most responses ongoing as of the data cutoff date of September 18, 2023. In the evaluable patient population, 20 had cutaneous squamous cell carcinoma and three had merkel cell carcinoma. Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. Additional biomarker data collected showed an increase in CD+8 T, a type of immune cell, and an increase in the expression of PD-L1, after treatment suggesting immune activation.