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: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.