Tuhura Biosciences Inc. has announced the presentation of a Trial in Progress poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting detailing their upcoming Phase 3 trial. The study will evaluate IFx-Hu2.0 as an adjunctive therapy with Keytruda® (pembrolizumab) in checkpoint inhibitor-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC). Conducted under an Accelerated Approval Pathway and Special Protocol Assessment agreement with the U.S. Food and Drug Administration, the trial aims to enroll 118 participants across 22 to 25 U.S. sites. The primary endpoint is overall response rate, with secondary endpoints including progression-free survival, safety, duration of response, and overall survival. The trial is designed to assess the efficacy of IFx-Hu2.0 in combination with pembrolizumab compared to a placebo, with the treatment regimen extending for up to two years.
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