Zhi Tong Cai Jing·2025-11-03 00:18Core Viewpoint - He Yu Pharmaceutical announced the completion of the first patient dosing in a Phase II clinical study of its oral small molecule PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, Goresir, for the treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutations [1] Group 1: Clinical Study Details - The open-label Phase II clinical study aims to evaluate the safety, tolerability, and efficacy of ABSK043 combined with Goresir in patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - The study received approval from the National Medical Products Administration (NMPA) in China for a new drug clinical trial (IND) in August 2025 [1] - The successful dosing of the first patient marks a significant step in the clinical development of this promising combination therapy [1] Group 2: KRAS G12C Mutation Context - KRAS is the most common oncogenic driver gene in human cancers, with an occurrence rate of approximately 14% for KRAS G12C mutations in NSCLC patients [1] - The oral small molecule PD-L1 inhibitor ABSK043 has shown good safety and potential anti-tumor activity as a monotherapy in previous Phase I clinical studies involving advanced solid tumor patients, particularly in groups with high PD-L1 expression, EGFR mutations, and KRAS mutations [1]