Core Viewpoint - The approval of sac-TMT (also known as SKB264/MK-2870) for a third indication by the National Medical Products Administration (NMPA) represents a significant advancement in the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1: Drug Approval and Indications - The NMPA has approved sac-TMT for treating adult patients with locally advanced or metastatic non-squamous NSCLC who have progressed after TKI treatment [1] - Sac-TMT is the first and only antibody-drug conjugate (ADC) to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy [1][2] - The approval is based on the results of the OptiTROP-Lung04 study, which evaluated the efficacy and safety of sac-TMT compared to pemetrexed plus platinum-based therapy [2] Group 2: Clinical Study and Results - The OptiTROP-Lung04 study is a randomized, open-label, multicenter Phase III clinical trial that will present its findings at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study aims to assess the effectiveness of sac-TMT administered every two weeks at a dose of 5 mg/kg via intravenous injection against standard treatment in patients with EGFR mutation-positive NSCLC who have failed EGFR-TKI therapy [2] - Sac-TMT has shown statistically and clinically significant improvements in progression-free survival and overall survival compared to standard platinum-based chemotherapy [1][2]
科伦博泰生物-B(06990)：核心产品TROP2ADC芦康沙妥珠单抗(SAC-TMT)获国家药品监督管理局批准第三项适应症上市，用于治疗EGFR-TKI治疗后进展的EGFR突变非小细胞肺癌