AKESO(HK:09926) 智通财经网·2025-10-20 00:21Core Insights - The clinical trial results of HARMONi-6 / AK112-306 were prominently presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivosidenib combined with chemotherapy for advanced sq-NSCLC [1][2] Group 1: Clinical Trial Overview - HARMONi-6 / AK112-306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivosidenib combined with chemotherapy versus Toripalimab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1][2] - The study enrolled 532 participants, with 92.3% of subjects in clinical stage IV, and the characteristics of squamous cell carcinoma were consistent with real-world patient distribution [1][2] Group 2: Key Findings - Ivosidenib combined with chemotherapy achieved a significant improvement in progression-free survival (PFS) compared to Toripalimab, with a hazard ratio (HR) of 0.60 and a p-value of <0.0001 [1] - The median PFS for the Ivosidenib group was 11.14 months, while the control group had a median PFS of 6.9 months, resulting in an absolute improvement of 4.24 months [1] Group 3: Subgroup Analysis - Significant benefits of Ivosidenib were observed across various subgroups, including those with different PD-L1 expression levels and liver metastasis status [1] - In the PD-L1 negative population, the median PFS was 9.9 months versus 5.7 months (HR = 0.55) [1] - In the PD-L1 positive population, the median PFS was 12.6 months versus 8.6 months (HR = 0.66) [1] Group 4: Safety Profile - The overall safety profile of the Ivosidenib group was favorable, with no new safety signals identified, and the incidence of treatment-related serious adverse events was similar to the control group [1]