HONG KONG, March 31, 2026 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) announced 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).
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.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has established a robust R&D innovation ecosystem centered on its Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
Forward-Looking Statements
This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
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