Ivonescimab Versus Pembrolizumab in First-Line PD-L1-Positive NSCLC: Positive Overall Survival Results from HARMONi-2 Presented at WCLC 2026

HONG KONG, Sept. 13, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) today announced the presentation of positive overall survival (OS) results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study (AK112-303) at the 2026 World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). The study evaluated the company's first-in-class next-generation immuno-oncology therapy, ivonescimab, versus pembrolizumab as first-line treatment for patients with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

The findings were selected as a Late-Breaking Abstract (LBA) for oral presentation and included in the official WCLC press program.

On September 13, the WCLC official website published the Abstract data on overall survival (OS) from the HARMONi-2 study. On September 15, Professor Caicun Zhou, Principal Investigator of HARMONi-2, IASLC President, and Director of the Department of Oncology at Shanghai East Hospital, will deliver the formal oral presentation (Oral) at the conference, sharing the complete results of the HARMONi-2 study with the global industry.

As of the data cutoff on August 20, 2026, the median follow-up was 36 months, and a total of 234 overall survival (OS) events had occurred. For this OS analysis, a prespecified O'Brien-Fleming spending function was used, with a one-sided alpha of 0.0141.

Results showed that, compared with pembrolizumab, first-line treatment with ivonescimab significantly prolonged OS in patients with PD-L1-positive advanced NSCLC.  This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit. The overall survival benefit was generally consistent across prespecified subgroups, with particularly pronounced benefit observed in the PD-L1-high population.

1. Intention-to-Treat (ITT) Population: Median OS of 30.8 Months with Ivonescimab, 27% Reduction in Risk of Death

• In the ITT population, ivonescimab monotherapy significantly prolonged OS versus pembrolizumab, with median OS of 30.8 months versus 22.6 months (HR=0.73; 95% CI: 0.57–0.95; P=0.009), corresponding to a 27% reduction in the risk of death.

2. Overcoming Traditional Anti-VEGF Treatment Contraindications: No Significant Increase in Bleeding Risk Observed in High-Risk Squamous Patients

Squamous NSCLC patients accounted for 45.5% of the HARMONi-2 population, and non-squamous patients for 54.5%. Among squamous patients treated with ivonescimab, 72.2% had central tumors, 10.0% had tumor cavitation or necrosis, and 6.7% had tumors encasing major vessels.

These populations are traditionally considered contraindicated or high-risk for anti-VEGF therapies and have long lacked effective treatment options. However, no apparent increase in bleeding risk was observed with ivonescimab, and these patients showed favorable benefit.

3. Consistent OS Benefit with Ivonescimab Regardless of PD-L1 Expression Level, with Particularly Pronounced Benefit in the TPS ≥50% Population

• In the PD-L1 TPS ≥50% subgroup, OS HR=0.58 (95% CI: 0.38–0.89), corresponding to a 42% reduction in the risk of death.
• In the PD-L1 TPS 1–49% subgroup, OS HR=0.85 (95% CI: 0.61–1.18), corresponding to a 15% relative reduction in the risk of death.

4. Consistent OS Benefit with Ivonescimab Regardless of Histology (Squamous and Non-Squamous)

• In the squamous cell carcinoma subgroup, OS HR=0.65 (95% CI: 0.45–0.95), corresponding to a 35% reduction in the risk of death.
• In the non-squamous subgroup, OS HR=0.79 (95% CI: 0.55–1.14), corresponding to a 21% reduction in the risk of death.

5. Favorable Overall Safety Profile with No New Safety Signals; Safety Characteristics Generally Consistent Between Arms

In May 2024, a prespecified interim analysis of progression-free survival (PFS) assessed by the Independent Data Monitoring Committee (IDMC) confirmed that HARMONi-2 met its primary PFS endpoint with statistically significant and clinically meaningful results. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab (HR=0.51, P<0.0001). This indication was approved in China in 2025.

HARMONi-2 is the first randomized, double-blind, controlled Phase III clinical study to demonstrate statistically significant positive OS and PFS results versus pembrolizumab.

An international multicenter Phase III clinical study evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for PD-L1-high NSCLC (HARMONi-7/AK112-3007) is currently progressing efficiently.

To date, ivonescimab has consistently achieved dual-positive OS and PFS results across multiple Phase III head-to-head trials against PD-1/L1 therapies and continues to expand into major solid tumors beyond lung cancer. The synergistic antitumor effects of ivonescimab's dual "immuno-oncology + anti-angiogenesis" mechanism continue to be validated in both clinical research and real-world settings. Ivonescimab has the potential to provide a more effective treatment option with a manageable safety profile for cancer patients worldwide and to drive continued progress in oncology care.

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, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary 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.

Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multispecific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval.

Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world.

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 the 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.