宋尔卫院士团队最新论文：国产ADC新药，安全有效治疗乳腺癌等多种晚期实体瘤

Core Viewpoint - SHR-A1811, a novel HER2-targeting antibody-drug conjugate (ADC) developed by Suzhou Merrion Biopharmaceuticals, shows significant antitumor activity and safety in advanced solid tumor patients who have undergone extensive prior treatments [2][11]. Group 1: Clinical Development and Efficacy - The global phase 1 trial of SHR-A1811 demonstrated long-term efficacy and good safety in patients with advanced solid tumors, including breast cancer, cholangiocarcinoma, and urothelial carcinoma [2][11]. - The trial involved 396 patients who had previously received 2-4 treatment regimens, with a median follow-up of 17.1 months for HER2-positive breast cancer patients [8]. - The median progression-free survival (PFS) was reported as 25.0 months for HER2-positive breast cancer patients and 11.0 months for HER2 low-expressing breast cancer patients [8]. Group 2: Safety Profile - The safety profile of SHR-A1811 was consistent with previous reports, with 65.9% of patients experiencing grade 3 or higher treatment-related adverse events [8]. - Only 2.5% of patients experienced any level of interstitial lung disease, indicating a relatively low risk associated with this treatment [8]. Group 3: Mechanism and Advantages - SHR-A1811 combines trastuzumab with a cleavable linker and a topoisomerase I inhibitor, showing superior membrane permeability and cytotoxicity compared to T-DXd [6]. - The drug exhibits a good safety profile with a drug-to-antibody ratio of 6 and a low release rate of toxic payloads, suggesting its potential as a safer alternative in HER2-targeted therapies [6][11].