Core Viewpoint - The company announced that its TROP2 ADC sac-TMT combined with pembrolizumab has achieved significant improvements in progression-free survival (PFS) in a Phase III clinical study for PD-L1 positive non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Study Results - The OptiTROP-Lung05 study reached its primary endpoint, showing statistically and clinically significant improvements in PFS, with a trend towards benefits in overall survival (OS) [1] - Sac-TMT is the first ADC to achieve the primary endpoint in first-line NSCLC treatment, and the company plans to communicate with the CDE regarding the NDA submission [1] - The study involved patients who were negative for EGFR sensitive mutations and ALK fusion genes, with the treatment regimen being sac-TMT (4 mg/kg Q2W) combined with pembrolizumab (400 mg Q6W) [1] Group 2: Market Potential and Demand - The first-line treatment market for NSCLC is vast, with approximately 1 million new lung cancer cases annually, of which about 85% are NSCLC, and around 50% of these patients have PD-L1 TPS ≥ 1% [2] - In mainland China, about 60% of patients are EGFR negative, and approximately 95% are ALK negative, indicating a significant unmet treatment need [2] - The 2025 CSCO guidelines still primarily recommend PD-(L)1 monoclonal antibodies and chemotherapy for first-line treatment of driver gene-negative NSCLC [2] Group 3: Comparative Efficacy - Sac-TMT shows promising potential in first-line treatment for NSCLC, with a median PFS of 17.8 months in PD-L1 positive patients, outperforming Trodelvy combined with pembrolizumab, which had a median PFS of 13.1 months [3] - In patients with low PD-L1 expression (TPS < 1%), sac-TMT achieved a median PFS of 12.4 months, surpassing Dato-DXd's 9.3 months in a similar population [3] - The company is awaiting OS data and specific Phase III results for sac-TMT in wild-type NSCLC [3] Group 4: Ongoing Development and Future Potential - Merck is actively advancing the clinical development of sac-TMT, with 15 global Phase III trials across six cancer types, including lung cancer [4] - The company is conducting four clinical trials in the NSCLC field, focusing on various combinations and treatment regimens [4] Group 5: Efficacy in Specific Patient Populations - In the OptiTROP-Lung04 Phase III study, sac-TMT demonstrated an overall response rate (ORR) of 60.6% compared to 43.1% for chemotherapy, with a median PFS of 8.3 months versus 4.3 months [5] - The analysis indicated that sac-TMT significantly improved OS compared to chemotherapy, reducing the risk of death by 40% [5] Group 6: Financial Projections - The company expects revenues of 2.084 billion, 2.876 billion, and 4.663 billion yuan for the years 2025 to 2027, with net profits of -622 million, -130 million, and 561 million yuan respectively [5]
科伦博泰生物-B(06990.HK)：PD-L1阳性NSCLC 1L的III期临床达到主要终点 一线治疗市场广阔