ZAI LAB (09688): Latest Update on Amgen's Bemarituzumab FORTITUDE-101 Phase III Clinical Trial

Stock News
Sep 03

ZAI LAB (09688) announced that according to Amgen, the company's partner and sponsor of the study, the FORTITUDE-101 Phase III clinical trial evaluating bemarituzumab in combination with chemotherapy (mFOLFOX6) for first-line gastric cancer treatment has completed its final analysis. During the study's pre-specified interim analysis (the primary analysis), the bemarituzumab plus chemotherapy regimen demonstrated statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone. However, in the final analysis, the previously observed survival benefit magnitude was diminished. Amgen stated that results from both the interim and final analyses will be presented at upcoming major medical conferences. Based on the updated results from the FORTITUDE-101 study, the company plans to await results from the FORTITUDE-102 study (which aims to evaluate bemarituzumab in combination with nivolumab plus chemotherapy in the same patient population) before submitting registration applications. Data from the FORTITUDE-102 study is expected to be released in late 2025 or the first half of 2026.

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