Core Insights - The SAFFRON study has completed patient enrollment, focusing on the combination therapy of savolitinib (ORPATHYS®) and osimertinib (TAGRISSO®) for treating advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations and MET overexpression or amplification after progression on prior TAGRISSO® treatment [1][2] - This combination therapy offers a promising oral treatment option without chemotherapy for patients who have progressed after one EGFR TKI treatment, having received approval in China based on results from the SACHI study [1] Group 1 - The SAFFRON study is a global Phase III, open-label, randomized trial assessing the efficacy of the combination therapy compared to platinum-based doublet chemotherapy in patients with advanced or metastatic NSCLC [2] - The primary endpoint of the study is progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to RECIST 1.1 criteria, with secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety [2] - A total of 338 patients from over 230 research centers across 29 countries have been randomized in the SAFFRON study, with top-line results expected to be announced in the first half of 2026 [2] Group 2 - If the results are favorable, the data from the SAFFRON study may support regulatory submission for the combination therapy to global regulatory authorities [2]
和黄医药(00013)宣布沃瑞沙®和泰瑞沙®联合疗法用于治疗泰瑞沙®治疗后疾病进展的伴有 MET过表达和/或扩增的特定肺癌患者的SAFFRON全球III期研究完成患者入组