Phase II Study of Ivonescimab in the Perioperative Setting for Resectable NSCLC Published in Nature Medicine

Phase II Study of Ivonescimab in the Perioperative Setting for Resectable NSCLC Published in Nature Medicine

PR Newswire

HONG KONG, Nov. 5, 2026

HONG KONG, Nov. 5, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) today announced that results from a Phase II clinical study evaluating its first-in-class PD-1/VEGF bispecific antibody ivonescimab in the perioperative treatment of resectable non-small cell lung cancer (NSCLC) have been published in the journal Nature Medicine. This Phase II trial assessed the efficacy and safety of perioperative ivonescimab administered either as monotherapy or in combination with chemotherapy. Patients received neoadjuvant treatment followed by surgical resection and subsequent adjuvant ivonescimab.

The study demonstrated that neoadjuvant ivonescimab in combination with chemotherapy produced high rates of pathological response in patients with resectable NSCLC. Among patients who underwent surgery, the major pathological response (MPR) rate was 70.1% and the pathological complete response (pCR) rate was 50.7%.

Key findings:

• In the ivonescimab plus chemotherapy cohort, the MPR rate reached 70.1%, the pCR rate was 50.7%, and 68.7% of patients had residual viable tumor (RVT) ≤5%.
• The ivonescimab monotherapy cohort also showed meaningful pathological responses, with an MPR rate of 60.0% and a pCR rate of 30.0%.
• Both cohorts achieved high objective response rates and frequent T-stage downstaging. All patients who proceeded to surgery achieved R0 resection (100%). The 12-month event-free survival (EFS) rates exceeded 80% in both arms, comparing favorably with outcomes reported in prior Phase III perioperative immunotherapy trials.
• Subgroup analyses revealed particularly notable activity in clinically relevant populations: patients with squamous histology achieved an MPR rate of 81.5% and a pCR rate of 61.1%; those with Stage III disease achieved an MPR rate of 65.5% and a pCR rate of 47.3%; and PD-L1-negative patients achieved an MPR rate of 69.2%, comparable to that observed in PD-L1-positive patients.
• The perioperative safety profile of ivonescimab was manageable. No grade ≥3 bleeding events occurred, and no surgeries were cancelled due to treatment-related adverse events.

Approximately one-quarter of patients with NSCLC have resectable disease at the time of diagnosis. Nevertheless, 30–70% of patients experience disease recurrence after surgery, frequently with distant metastases, contributing to poor long-term outcomes. Although neoadjuvant immuno-chemotherapy is now established in treatment guidelines, current regimens leave room for improvement, particularly in subgroups such as Stage IIIB disease, squamous histology, and PD-L1-negative tumors, where unmet clinical need remains substantial.

These Phase II results further support the potentially important role of ivonescimab as a next-generation immunotherapy option across the continuum of NSCLC treatment options.

About Ivonescimab

Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world's first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab.

Building on its strong clinical profile in the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company's IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide.

More than 17 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).

Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion.

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 multi-specific 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 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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