Core Viewpoint - The approval of the antibody-drug conjugate (ADC) sac-TMT for a third indication marks 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: Product Approval and Clinical Significance - The National Medical Products Administration (NMPA) has approved sac-TMT for treating adult patients with locally advanced or metastatic NSCLC who have progressed after TKI treatment [1] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1] - The treatment has demonstrated statistically and clinically significant improvements in progression-free survival (PFS) and OS compared to standard platinum-based chemotherapy [1] Group 2: Clinical Research and Future Developments - The approval is based on the results of a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed plus platinum-based therapy in patients with EGFR mutation-positive NSCLC who have failed EGFR-TKI treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC has completed patient enrollment in China [2]
科伦博泰生物-B：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