科伦博泰生物-B(06990.HK)：芦康沙妥珠单抗肺癌III期研究OS最终结果入选ELCC突破性摘要

Core Viewpoint - The company Kolon Biotech announced that the final analysis results of the overall survival (OS) from the OptiTROP-Lung03 clinical study of its antibody-drug conjugate (ADC) sac-TMT will be presented at the 2026 European Lung Cancer Conference (ELCC) in Copenhagen from March 25 to 28, 2026, with the study's abstract published in ESMO Open [1] Group 1 - The OptiTROP-Lung03 study aims to evaluate the efficacy and safety of sac-TMT monotherapy (5 mg/kg every two weeks) compared to docetaxel in patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) who have previously received EGFR-TKI and platinum-based chemotherapy [2] - Results presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting showed that among 137 randomized patients, sac-TMT demonstrated significant statistical and clinical improvements in progression-free survival (PFS) and OS compared to docetaxel, with a PFS hazard ratio (HR) of 0.30 (95% CI: 0.20–0.46, one-sided p<0.001) and an OS HR of 0.49 (95% CI: 0.27–0.88, one-sided p=0.007) [2] - Based on these positive results, sac-TMT received approval from the National Medical Products Administration (NMPA) for this indication, which has been included in the national medical insurance catalog [2] Group 2 - The 2026 ELCC will present the final analysis results of the OS from the OptiTROP-Lung03 study, along with updated PFS data, with a median follow-up time of 23.8 months as of December 11, 2025 [3] - In the docetaxel treatment control group, 41.3% of patients chose to receive subsequent sac-TMT treatment after disease progression. The median OS for the sac-TMT group was 20.0 months compared to 11.2 months for the docetaxel group (HR 0.45, 95% CI: 0.28–0.73), with 18-month OS rates of 54.7% vs 9.1% [3] - If the OS of the control group is not adjusted for subsequent sac-TMT treatment, the median OS for the two groups would be 20.0 months vs 13.5 months (HR 0.63, 95% CI: 0.40–0.98). The investigator-assessed median PFS was 7.9 months vs 2.8 months (HR 0.23, 95% CI: 0.15–0.35) [3]