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靶向免疫联合巩固治疗
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中国生物制药(01177.HK):贝莫苏拜单抗联合或不联合安罗替尼巩固治疗放化疗后未进展的非小细胞肺癌III期研究数据在2025年ASCO年会公布
Ge Long Hui· 2025-06-05 04:09
Core Insights - China Biologic Products (01177.HK) announced the latest results of a Phase III clinical study for Bemesumab injection combined with or without Anlotinib capsules for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [1][3] Group 1: Clinical Study Results - The study (R-ALPS) demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median progression-free survival (PFS) to 15.1 months compared to 4.2 months in the placebo group, reducing the risk of disease progression or death by 51% [1][2] - A total of 553 patients were randomized in the study, with 209 in the treatment group receiving Bemesumab and Anlotinib, 212 receiving Bemesumab and placebo, and 132 in the control group receiving placebo, with a median follow-up of 19.4 months [1][2] Group 2: Safety Profile - The safety profile of the treatment was consistent with known risks, with no new safety signals reported; the incidence of grade 3 or higher treatment-related adverse events was 48.8%, 29.4%, and 19.7% for the three groups respectively [2] Group 3: Industry Context - Lung cancer has the highest incidence and mortality rates among all malignancies globally, with 2.48 million new cases reported in 2022, of which 1.061 million were in China; NSCLC accounts for approximately 80%-85% of all lung cancer cases [2] - The R-ALPS study is the first of its kind in the field of combined therapy following concurrent or sequential chemoradiotherapy for unresectable stage III NSCLC, potentially reshaping clinical practice guidelines and benefiting more NSCLC patients [3]