Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced the approval of its IND application for the oral PD-L1 inhibitor ABSK043 in combination with the KRAS G12C inhibitor, citric acid gorasetinib, for treating KRAS G12C mutated non-small cell lung cancer (NSCLC) patients [1] Group 1 - The IND application was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China [1] - The study is an open-label Phase II clinical trial assessing the safety, tolerability, and efficacy of ABSK043 in combination with citric acid gorasetinib for patients with locally advanced or metastatic NSCLC carrying KRAS G12C mutations [1] - A previous collaboration between Heyu and Elysium was disclosed to explore the combination of ABSK043 with Elysium's developed drug, furmetinib, for treating advanced NSCLC, with the first patient dosing expected to be completed by December 2024 [1] Group 2 - Updated Phase I study results show that ABSK043 as a monotherapy has good safety and impressive anti-tumor activity, with higher response rates observed in patients with high PD-L1 expression and those with EGFR or KRAS mutations [1]
和誉-B(02256.HK):和誉医药的口服PD-L1抑制剂ABSK043与艾力斯的KRAS G12C抑制剂枸橼酸戈来雷塞片联合用药治疗NSCLC的IND申请获CDE批准