Ivonescimab

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. SOURCE Akeso, Inc. 21% more press release views with Request a Demo

Researchers across 79 centers in China reported that a combination regimen of programmed death-ligand 1 (PD-L1) inhibitor benmelstobart plus the multi-kinase inhibitor anlotinib produced statistically significant improvements in progression-free survival over pembrolizumab monotherapy in PD-L1-positive, driver gene-negative advanced non-small-cell lung cancer (NSCLC), according to the CAMPASS Phase III trial. The results were published in The Lancet Oncology. The trial, funded by Chia Tai Tianqing Pharmaceutical Group, enrolled 531 patients and represents one of the first randomized Phase III datasets to demonstrate head-to-head superiority over pembrolizumab in this setting. Chia Tai is responsible for discovering benmelstobart and development in Greater China, while US-based biotech Apollomics partnered with the China-based firm for rights outside China. Pembrolizumab monotherapy has held a dominant position as first-line treatment for PD-L1-positive advanced NSCLC since its approval based on the KEYNOTE-024 and KEYNOTE-042 trials. However, a substantial proportion of patients progress within a year, and response rates in the broader PD-L1-positive population—defined as tumor proportion score (TPS) of 1% or greater—remain around 30% to 40%. The CAMPASS trial was designed to test whether adding anlotinib, a multi-target anti-angiogenic tyrosine kinase inhibitor, to the PD-L1-targeted benmelstobart could improve outcomes without the addition of chemotherapy. The CAMPASS results The trial randomized patients 2:1, with 354 receiving benmelstobart plus anlotinib and 177 receiving pembrolizumab plus placebo. Patients were aged 18 to 75 years, had an ECOG performance status of 0 or 1, and had no targetable EGFR or ALK mutations. Both squamous and non-squamous histologies were included. Enrollment ran from August 2021 through December 2022 across 79 sites in China. The primary endpoint was progression-free survival assessed by blinded independent central review per RECIST v1.1. Median PFS in the experimental arm was not reached at the time of analysis, compared with 8.9 months in the pembrolizumab arm. The hazard ratio was 0.51 (95% CI: 0.39–0.67; p<0.0001). The 12-month PFS rate was approximately 60% with benmelstobart plus anlotinib versus approximately 40% with pembrolizumab. The PFS benefit was consistent across prespecified subgroups, including patients with TPS 1%–49% and ≥50%, as well as across squamous and non-squamous histologies. Overall survival data, while still maturing with both medians not yet reached, showed a hazard ratio of 0.62 (95% CI: 0.44–0.88; p0.007), indicating an early OS signal in favor of the combination. The objective response rate was approximately 63% in the experimental arm versus 39% in the pembrolizumab arm, a statistically significant difference. The mechanistic rationale for the combination centers on the relationship between tumor angiogenesis and immune suppression. Tumors upregulate VEGF signaling to promote vascular growth, but this process also creates an immunosuppressive microenvironment by reducing T-cell infiltration and promoting regulatory T-cell accumulation. Anlotinib inhibits VEGFR, FGFR, PDGFR, and c-Kit, which normalizes tumor vasculature and is thought to improve T-cell trafficking into the tumor. Benmelstobart then blocks the PD-1/PD-L1 axis, reactivating cytotoxic T-cells within a more accessible microenvironment. The hypothesis is that anti-angiogenic therapy potentiates checkpoint inhibition by making tumors more immunologically permissive, rather than relying on checkpoint blockade alone. The safety profile reflected the dual-agent mechanism. Grade 3 or higher treatment-related adverse events occurred in approximately 60% of patients in the benmelstobart plus anlotinib arm, compared with approximately 35% in the pembrolizumab arm. Anlotinib-related toxicities, particularly hypertension and proteinuria, accounted for a meaningful share of the higher adverse event burden. Treatment discontinuation rates were higher in the experimental arm, however, no new or unexpected safety signals were identified. The investigators characterized the toxicity as manageable with dose modifications. Research context The CAMPASS regimen represents one among several competing approaches to the same problem. Akeso’s ivonescimab, a bispecific antibody targeting both PD-1 and VEGF within a single molecule, reported superiority over pembrolizumab in the HARMONi-2 Phase III trial in 2024 in a Chinese PD-L1-positive NSCLC population. Summit Therapeutics holds ex-China rights to ivonescimab, and the asset has attracted considerable attention as a potential pembrolizumab alternative in the first-line setting. The bispecific format is mechanistically adjacent to the CAMPASS combination but consolidates both activities into one molecule, which may carry pharmacokinetic and dosing advantages. Other China-developed IO combinations—including camrelizumab plus apatinib from Jiangsu Hengrui and sintilimab plus anlotinib from Innovent—are also in late-stage evaluation in overlapping populations. Roche’s atezolizumab plus bevacizumab plus chemotherapy (IMpower150) is approved in non-squamous NSCLC but includes cytotoxic chemotherapy, a distinction that the CAMPASS regimen avoids. The chemotherapy-free design is a feature it shares with the ivonescimab approach, with both positioning against pembrolizumab monotherapy in PD-L1-positive advanced NSCLC. The CAMPASS dataset was generated entirely in China, which carries implications for regulatory and commercial strategy. The trial population reflects a Chinese clinical context, and generalizability to Western populations will require additional data or bridging studies before regulatory submissions outside China. The benmelstobart program is also being evaluated in extensive-stage small-cell lung cancer, where a Phase III trial published in Nature Medicine in 2024 suggests Chia Tai Tianqing is pursuing a broader oncology footprint for the combination platform. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website