AKESO (09926.HK): HARMONi-2 interim analysis of ivonescimab meets key secondary OS endpoint with statistical significance and clinical benefit

NewTimeSpace News: On 3 September 2026, Akeso, Inc. (stock code: 09926) announced that in the randomised, double-blind, controlled, multi-centre Phase III clinical study (AK112-303/HARMONi-2) evaluating the Company's self-developed, globally first-in-class bispecific antibody ivonescimab (PD-1/VEGF) monotherapy versus pembrolizumab monotherapy as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS≥1%), the pre-specified interim analysis of overall survival (OS) assessed by the Independent Data Monitoring Committee (IDMC) met the key secondary OS endpoint, achieving positive results with statistical significance and clinical benefit. Detailed data from the results will be presented at future international academic conferences and published in academic journals.

The study enrolled 398 subjects in total, with progression-free survival (PFS) as the primary endpoint and OS as the key secondary endpoint. In May 2024, the study met its primary PFS endpoint, with median PFS of 11.14 months and 5.82 months in the ivonescimab and control groups respectively, and a PFS HR of 0.51 (P<0.0001). The indication was approved for marketing in China in 2025; ivonescimab has overcome the contraindication of VEGF agents in patients with squamous carcinoma, offering patients a superior "chemo-free" option.

Ivonescimab (PD-1/VEGF) is the world's first-in-class PD-1/VEGF bispecific tumour immunotherapy drug, approved by the NMPA on 24 May 2024 for the treatment of EGFR-mutated non-squamous NSCLC progressing after EGFR-TKI therapy, with a new indication approved on 25 April 2025 for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC (both indications included in the latest National Reimbursement Drug List), and a further new indication approved on 12 August 2026 for first-line treatment of squamous NSCLC. Ivonescimab has initiated 60 Phase II/III clinical studies across more than 40 indications, including lung cancer, biliary tract cancer, head and neck squamous cell carcinoma and triple-negative breast cancer, of which 17 registrational Phase II/III clinical studies are being efficiently advanced.

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