TuHURA Biosciences Announces Phase 3 Trial for IFx-Hu2.0 as Adjunctive Therapy in Advanced Merkel Cell Carcinoma at ASCO 2025

Reuters
06-02
TuHURA Biosciences Announces Phase 3 Trial for IFx-Hu2.0 as Adjunctive Therapy in Advanced Merkel Cell Carcinoma at ASCO 2025

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Tuhura Biosciences Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA00748) on June 02, 2025, and is solely responsible for the information contained therein.

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