Mural Oncology provides update on ARTISTRY-6 cohort 2 at Investor Day

ARTISTRY-6 cohort 2 is a potentially registrational single arm study of single agent nemvaleukin in patients with unresectable or metastatic mucosal melanoma. The trial’s primary endpoint is overall response rate evaluated per RECIST 1.1 by an independent central radiology review. Secondary endpoints include duration of response, time to response, disease control rate, progression-free survival, and safety. Mucosal melanoma is a rare subtype of melanoma with poor prognosis and currently no approved treatment options. Nemvaleukin for the treatment of mucosal melanoma has received both FDA Fast Track Designation and Orphan Drug Designation. Enrollment in this study is complete with 92 patients enrolled. ARTISTRY-6, Cohort 2 Response Rate Assumptions and Rationale: The target response rate is 25%. At this target, the lower bound of the 95% confidence interval will exceed a 15% response rate. Mural believes that in this rare and highly aggressive tumor with poor outcomes even in the first line setting, demonstrating durable responses with a response rate of 20-25% would be meaningful for patients, and would support a discussion with the FDA regarding a potential BLA submission and potential accelerated approval. A potential accelerated approval would require confirmatory evidence to be agreed with and later submitted to the FDA for conversion to a regular approval. Discussions with FDA on a potential confirmatory evidence package are ongoing. The primary analysis will occur when all patients have a minimum follow-up of at least six months. In order to ensure adequate follow-up on all patients, Mural anticipates that the top-line readout will occur in the second quarter of 2025. Potential accelerated approval with confirmatory evidence to be later submitted for conversion to regular approval. Regulatory filing may be deferred if the ARTISTRY-7 study continues to final analysis, pending the final outcome.