Core Viewpoint - Kolonbo Tai Biotech's stock price reached a new high of 363 HKD per share, driven by the significant clinical data release of TROP2 ADC, Lukanosatuzumab, for treating EGFR-mutant advanced non-small cell lung cancer (NSCLC) at the 2025 ASCO annual meeting [2] Group 1: Clinical Research Findings - The OptiTROP-Lung03 study demonstrated that Lukanosatuzumab significantly improved clinical outcomes in EGFR-TKI and platinum-based chemotherapy-resistant patients compared to the docetaxel group, with better objective response rate (ORR), median progression-free survival (PFS), and median overall survival (OS) [3][4] - The study reported a median follow-up of 12.2 months, showing statistically significant advantages for the Lukanosatuzumab group, although OS data is not yet fully mature [4] - The safety profile of Lukanosatuzumab was manageable, with the most common grade 3 or higher treatment-related adverse events (TRAE) being neutropenia (42.9%), leukopenia (25.3%), oral mucositis (16.5%), and anemia (12.1%) [4] Group 2: Regulatory Approval and Market Potential - Based on the positive results from the OptiTROP-Lung03 study, the National Medical Products Administration (NMPA) of China has approved Lukanosatuzumab for post-line treatment of EGFR-mutant NSCLC, making it the first TROP2 ADC approved for lung cancer indications globally [4] - The success of Lukanosatuzumab represents a significant breakthrough in clinical research and enhances the drug's accessibility in clinical practice, especially as previous similar Phase III trials abroad did not achieve approval [4] - The treatment strategy for TROP2 ADC Lukanosatuzumab is expanding from post-line to first-line therapy and from monotherapy to combination therapy [5] Group 3: Treatment for Rare EGFR Mutations - A Phase II open-label, multi-cohort study presented at ASCO evaluated the efficacy and safety of Lukanosatuzumab in previously treated patients with rare EGFR mutations, showing promising clinical activity with an ORR of 35.7% and a disease control rate (DCR) of 85.7% [6] - The study included 42 patients with rare EGFR mutations, with a median follow-up of 9.9 months, indicating a median PFS of 9.5 months and a 6-month duration of response (DoR) rate of 90.9% [6] - These results highlight the potential of Lukanosatuzumab as a new treatment option for patients with non-classical EGFR mutations [6]
2025年ASCO中国之声：突破耐药、填补空白 科伦博泰生物芦康沙妥珠单抗展现EGFR突变非小细胞肺癌治疗前景