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和誉-B(02256):和誉医药于ESMO Asia 2025公布口服PD-L1抑制剂ABSK043联合 EGFR抑制剂伏美替尼治疗NSCLC的II期临...
Zhi Tong Cai Jing· 2025-12-08 00:15
Core Viewpoint - The announcement by He Yu-B (02256) highlights positive results from the Phase II clinical study of the oral small molecule PD-L1 inhibitor ABSK043 in combination with the third-generation EGFR-TKI, Furmonertinib, for treating non-small cell lung cancer (NSCLC) [1][2]. Group 1: Clinical Study Results - The Phase II study (ABSK043-202) included 21 patients with EGFR mutations and PD-L1 positivity, of which 17 had previously received third-generation EGFR-TKIs [2]. - The combination of ABSK043 and Furmonertinib demonstrated controllable safety and good tolerability, with no dose-limiting toxicities (DLTs) or interstitial lung disease (ILD) observed [2]. - The most common treatment-related adverse events (TEAEs) were grade 1-2, with no grade 4 or 5 TEAEs reported [2]. Group 2: Antitumor Activity - The combination therapy showed promising antitumor activity, achieving a disease control rate (DCR) of 71%, with 14 patients experiencing tumor shrinkage [3]. - Among the 5 patients who achieved partial response (PR), 4 had previously been treated with third-generation EGFR-TKIs [3]. - The results indicate that the ABSK043 and Furmonertinib combination not only has controllable safety and good tolerability but also exhibits encouraging initial antitumor activity, paving the way for further evaluation in the ongoing dose expansion phase [3].
和誉-B:和誉医药于ESMO Asia 2025公布口服PD-L1抑制剂ABSK043联合 EGFR抑制剂伏美替尼治疗NSCLC的II期临床初步结果
Zhi Tong Cai Jing· 2025-12-08 00:10
Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced positive results from the Phase II clinical study (ABSK043-202) of its oral small molecule PD-L1 inhibitor ABSK043 combined with the third-generation EGFR-TKI, Furmonertinib, for the treatment of non-small cell lung cancer (NSCLC) at the ESMO Asia 2025 conference [1][2]. Group 1: Clinical Study Results - The study included 21 patients with EGFR mutations and positive PD-L1 expression, of which 17 had previously received third-generation EGFR-TKIs [2]. - The combination of ABSK043 and Furmonertinib demonstrated controllable safety and good tolerability, with no dose-limiting toxicities (DLTs) or interstitial lung disease (ILD) observed [2]. - The most common treatment-related adverse events (TEAEs) were grade 1-2, with no grade 4 or 5 TEAEs reported [2]. Group 2: Antitumor Activity - The combination therapy showed promising antitumor activity, achieving a disease control rate (DCR) of 71%, with 14 patients experiencing tumor shrinkage [3]. - Among the 5 patients who achieved partial response (PR), 4 had previously been treated with third-generation EGFR-TKIs [3]. - The results indicate that the ABSK043 and Furmonertinib combination therapy could potentially overcome the toxicity challenges faced by previous EGFR-TKIs and immune therapy antibody combinations, laying the groundwork for the ongoing dose expansion phase [3].