全球制药业洞察 | 肺癌试验告捷！2025欧洲肿瘤内科学会大会亮点成果

Core Viewpoint - The article discusses the successful results of the HARMONi-6 trial by Akeso and Summit for a new immunotherapy targeting lung cancer, highlighting the need for survival data validation despite promising efficacy results [3][4]. Group 1: HARMONi-6 Trial Results - The HARMONi-6 trial demonstrated significant efficacy for the PD-1 xVEGF bispecific antibody therapy in treating squamous non-small cell lung cancer (NSCLC), with a progression-free survival (PFS) hazard ratio of 0.60 [4][5]. - The control group's PFS was slightly lower than previous trials, recorded at 6.9 months compared to 7.6 months [4]. - The HARMONi-3 trial, which will validate the efficacy globally, is expected to release data in the first half of 2026 [4][5]. Group 2: Safety Profile and Efficacy Comparison - The safety profile of the ivonescimab combined with chemotherapy was notably good, with low rates of severe VEGF-related events, including hypertension (3%), proteinuria (2%), and bleeding (1.9%) [7]. - The trial showed a 76% overall response rate (ORR) and a median duration of response (DOR) of 11.2 months [6][8]. - Comparatively, the KEYNOTE-407 trial by Merck reported a median overall survival (OS) of 17.2 months, establishing a benchmark for squamous NSCLC treatment [4][6]. Group 3: Competitive Landscape - Huabo Biopharm's HB0025 trial introduced another PD-(L)1 x VEGF bispecific antibody candidate, showing an 85% response rate in squamous NSCLC patients [9]. - The article notes that other pharmaceutical companies are likely to explore similar strategies in the competitive landscape of immuno-oncology [9].