Core Viewpoint - The company Yuzhiyou Biotech (02496) has announced mid-term data from its Phase II clinical trial of the bispecific antibody M701 for treating malignant pleural effusion caused by advanced non-small cell lung cancer (NSCLC), which was presented at the 2025 European Society for Medical Oncology (ESMO) conference [1] Group 1: Clinical Trial Overview - The study is a randomized, controlled, multicenter, open-label Phase II trial (code name: M70103) focusing on malignant pleural effusion in advanced NSCLC [2] - Participants were randomly assigned in a 1:1 ratio to either the treatment group receiving M701 or the control group receiving cisplatin after thoracentesis [2] - The primary endpoint is puncture-free survival (Pu FS), while secondary endpoints include objective response rate (ORR), time to next puncture (TTNP), and related symptoms [2] Group 2: Patient Demographics - As of March 7, 2025, 54 eligible patients with symptomatic malignant pleural effusion were enrolled, with 26 in the treatment group and 28 in the control group [3] - The median age was 66.5 years for the treatment group and 61.5 years for the control group, with a balanced baseline condition between the two groups [3] Group 3: Efficacy Results - The treatment group showed a longer median puncture-free survival of 130 days compared to 85 days in the control group, with a hazard ratio (HR) of 0.80 [4] - Notably, patients without driver gene mutations benefited significantly, with a median survival not reached compared to 44.5 days in the control group [4] - The objective response rate for malignant pleural effusion was 72.7% in the treatment group versus 41.7% in the control group [4] Group 4: Safety Results - The incidence of treatment-related adverse events was 3.7% for M701 compared to 10% for cisplatin, with only one serious adverse event linked to M701 [4] Group 5: Conclusion and Future Plans - M701 demonstrated significant efficacy and good tolerability compared to cisplatin, supporting further clinical development, especially for NSCLC patients without driver gene mutations [5] - A pivotal Phase III trial is planned to start in 2026 to validate the efficacy and safety of M701 in a larger Chinese population [5]
友芝友生物-B(02496)：M701恶性胸水II期研究中期数据在2025年ESMO会议上公布