Zai Lab to wait on results of FORTITUDE-102 prior to regulatory filing

The following announcement was made by Zai Lab (ZLAB) pursuant to Rule 13.09(2)(a) of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: “According to Amgen (AMGN), the company’s partner and study sponsor, the final analysis of the Phase 3 FORTITUDE-101 trial evaluating bemarituzumab in combination with chemotherapy in first-line gastric cancer has been completed. At the pre-specified interim analysis, which was the primary analysis, the bemarituzumab plus chemotherapy regimen demonstrated a clinical and statistically significant improvement in overall survival compared to chemotherapy alone. However, at the final analysis, the magnitude of the previously observed survival benefit has attenuated. Amgen has indicated that the results from both the interim analysis and final analysis will be presented at an upcoming major medical meeting. Based on the updated results of the FORTITUDE-101 trial, the company intends to await the results of FORTITUDE-102, evaluating bemarituzumab in combination with nivolumab and chemotherapy in the same patient population, prior to regulatory filing. Data readout from FORTITUDE-102 is anticipated by the end of 2025 or the first half of 2026.”