Core Viewpoint - Kangfang Biopharma (09926.HK) announced significant results from the HARMONi-6/AK112–306 study, which were presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, indicating a strong clinical benefit of Ivoris combined with chemotherapy over Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1] Group 1: Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1] - The primary endpoint of the study is progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1, with key secondary endpoints including overall survival (OS) [1] - A total of 532 subjects were enrolled in the HARMONi-6 study, with baseline characteristics balanced between the two groups, and 92.3% of subjects being classified as stage IV [1] Group 2: Study Results - The trial results demonstrated that Ivoris combined with chemotherapy achieved the primary endpoint of PFS, showing a decisive positive outcome with significant statistical and clinical benefits [1] - The Ivoris group significantly extended patient PFS compared to the control group, aligning with real-world patient distribution, where approximately 63% of cases were central squamous cell carcinoma [1]
康方生物(09926.HK):依沃西联合化疗对比替雷利珠联合化疗一线治疗晚期sq-NSCLC的HARMONi-6研究结果在柳叶刀& 2025 ESMO重磅发表