肺癌治疗研究
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百利天恒自主研发的iza-bren治疗EGFR突变肺癌的一项研究客观缓解率达100%
Zheng Quan Ri Bao· 2025-09-15 07:35
Group 1 - Sichuan Baili Tianheng Pharmaceutical Co., Ltd. announced that its self-developed drug, iza-bren (EGFR×HER3 dual antibody ADC), has been recognized at the 2025 World Lung Cancer Conference (WCLC) with two research results selected for the official press program [2] - The phase II study results of iza-bren combined with Osimertinib for patients with locally advanced or metastatic EGFR mutation non-small cell lung cancer (NSCLC) were presented by Professor Zhou Fei from the Eastern Hospital of Tongji University, involving 154 patients [2] - Among the 40 patients receiving the 2.5 mg/kg D1D8Q3W dose of iza-bren combined with Osimertinib, the objective response rate (ORR) reached 100%, with a progression-free survival (PFS) rate of 92.1% and overall survival (OS) rate of 94.8% at 12 months [3] Group 2 - A separate study led by Professor Fang Wenfeng from Sun Yat-sen University Cancer Center on the monotherapy of iza-bren for patients with locally advanced or metastatic EGFR mutation NSCLC showed a median PFS of 12.5 months and a tumor shrinkage rate of 94% among 50 patients previously treated with EGFR-TKI [3] - The ongoing phase III studies for both combination and monotherapy of iza-bren are being conducted globally and in China, with the first patient already dosed in the registration phase [3]
和黄医药(00013.HK)完成沃瑞沙® 和泰瑞沙®联合疗法用于一线治疗特定肺癌患者的SANOVO中国III期研究患者入组
Ge Long Hui· 2025-08-20 00:14
Group 1 - The core viewpoint of the news is that Hutchison China MediTech has completed patient enrollment for the SANOVO Phase III study, which evaluates the combination therapy of savolitinib and osimertinib for specific non-small cell lung cancer patients with EGFR mutations and MET overexpression [1][2] - The SANOVO study is a randomized controlled trial assessing the efficacy and safety of the combination therapy compared to osimertinib monotherapy, which is the current standard treatment for these patients [1] - The primary endpoint of the study is progression-free survival (PFS), 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 [1] Group 2 - Topline results from the SANOVO study are expected to be announced in the second half of 2026, followed by submission of the results to appropriate academic conferences [2] - If the results are favorable, Hutchison China MediTech plans to submit a new indication application to the National Medical Products Administration of China [2] - Savolitinib is described as a potent and highly selective oral MET tyrosine kinase inhibitor developed jointly by AstraZeneca and Hutchison China MediTech, while osimertinib is characterized as an irreversible third-generation EGFR TKI [2]