On March 31, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the results of health-related quality of life (HRQoL) data (Poster: 107P) from the HARMONi-2 study at the 2026 European Lung Cancer Congress (ELCC). The study evaluated ivonescimab, the company’s first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as a first-line treatment for patients with PD-L1–positive non-small cell lung cancer (NSCLC).

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In the primary analyses of HARMONi-2, ivonescimab demonstrated a median progression-free survival (PFS) of 11.14 months compared with 5.82 months for pembrolizumab (HR = 0.51; P < 0.0001), representing a 49% reduction in the risk of disease progression or death, with a manageable safety profile. The exploratory analysis presented at ELCC 2026 focuses on the other key pillar of treatment evaluation: HRQoL. The HRQoL analysis was conducted with the QLQ-C30, QLQ-LC13, and EQ-5D-5L instruments, showed that in the chemotherapy-free setting, ivonescimab not only significantly extended PFS but also delivered meaningful improvements in health-related quality of life. These findings provide additional, robust evidence to support the broad clinical use of ivonescimab and reinforce its role as a new standard of care (SOC) in first-line lung cancer treatment.

Key Findings:

Global health and functional status with sustained improvements and delayed deterioration:

In the primary analysis of HARMONi-2, in the ivonescimab group, the median time to deterioration (TTD) in global health status/quality of life (GHS/QoL) was not reached (vs 9.9 months for pembrolizumab), and the 12-month deterioration-free rate was 51% (vs 46%). The results published at ELCC2026, scores for GHS/QoL, physical function, and emotional function improved from baseline in both arms. In the ivonescimab arm, the mean GHS/QoL score increased from 71.8 (SD 17.6) at baseline to 78.5 (SD 15.9) at week 12 and remained stable at 78.5 (SD 16.0) at week 30. In the pembrolizumab arm, the mean score improved from 73.6 (SD 17.5) at baseline to 76.7 (SD 16.6) at week 12 and decreased slightly to 76.5 (SD 16.9) by week 30.

Better control of key lung cancer symptoms, with a sustained advantage in dyspnea:

According to the EORTC QLQ-LC13 lung cancer-specific questionnaire, patients in the ivonescumab group experienced sustained reductions in scores for cough, hemoptysis, and dyspnea.

Cough: Median TTD was not reached; the mean score decreased from 29.9 (SD 23.3) at baseline to 19.0 (SD 18.2) at week 12 and 19.6 (SD 21.7) at week 30.

Hemoptysis: The mean score decreased from 7.2 (SD 14.6) at baseline to 2.9 (SD 9.5) at week 30.

Dyspnea: Ivonescumab showed a trend toward superior long-term control, with the mean score decreasing from 17.5 (SD 16.0) at baseline to 12.1 (SD 14.6) at week 30.

High and stable health utility values:

On the EQ-5D-5L visual analog scale (VAS), the mean health status score increased from 81.9 (SD 13.5) at baseline to 84.3 (SD 10.6) at week 12 and remained high at 83.7 (SD 11.4) at week 30. Health utility values, which reflect overall patient well-being, remained consistently high throughout ivonescimab treatment, with mean values of approximately 0.9 (SD 0.1) at baseline, week 12, and week 30.

Based on the HARMONi-2 results, ivonescimab became the first therapy to show a significant PFS benefit over pembrolizumab in a head-to-head Phase III study. Ivonescimab was approved in 2025 in China as a first-line treatment for patients with PD-L1-positive NSCLC, establishing a novel, more effective, and safer chemotherapy-free option. To date, the breakthrough clinical value of ivonescimab has been demonstrated in dozens of clinical trials and real-world experience involving more than 70,000 patients.

(Press release, Akeso Biopharma, MAR 31, 2026, View Source [SID1234664094])