ADC+PD - L1单抗联合治疗

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Nature Medicine:中山大学方文峰/张力团队发布ADC+PD-L1单抗一线治疗晚期肺癌的2期临床数据
生物世界· 2025-08-21 10:30
Core Viewpoint - Sacituzumab tirumotecan (sac-TMT), developed by Kelun-Botai, is a TROP2-targeted antibody-drug conjugate approved for treating advanced triple-negative breast cancer and is undergoing multiple clinical trials for other cancers, including non-small cell lung cancer (NSCLC) [3][4]. Group 1: Clinical Research Findings - The paper published in Nature Medicine presents the results of the OptiTROP-Lung01 study, which evaluates sacituzumab tirumotecan combined with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients with driver gene negativity [4][6]. - This study is the third publication from the research team, following earlier studies on sacituzumab tirumotecan's efficacy in NSCLC [4]. Group 2: Treatment Protocols - In Cohort 1A (40 patients), the treatment regimen includes sacituzumab tirumotecan (5 mg/kg every 3 weeks) combined with tagitanlimab (1200 mg every 3 weeks) [7]. - In Cohort 1B (63 patients), the regimen consists of sacituzumab tirumotecan (5 mg/kg every 2 weeks) combined with tagitanlimab (900 mg every 2 weeks) [7]. Group 3: Safety and Efficacy Results - The most common ≥3 grade treatment-related adverse events (TRAE) in Cohorts 1A and 1B were neutropenia (30.0% vs 34.9%), leukopenia (5.0% vs 19.0%), and anemia (5.0% vs 19%), with no treatment-related deaths reported [9]. - The objective response rates (ORR) were 40.0% (16/40) for Cohort 1A and 66.7% (42/63) for Cohort 1B, with disease control rates of 85.0% and 92.1%, respectively. The median progression-free survival (PFS) was 15.4 months for Cohort 1A, while it has not yet been reached for Cohort 1B [10]. - Overall, the combination of sacituzumab tirumotecan and tagitanlimab shows superior efficacy compared to current standard treatments for advanced NSCLC patients with driver gene negativity, indicating a potential new standard for first-line therapy [10].