HONG KONG, Dec. 12, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The study will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab as first-line treatment for HER2-negative, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma.

This is the second international registrational study for cadonilimab, following the ongoing trial in immunotherapy-resistant hepatocellular carcinoma. COMPASSION-37 represents a pivotal advancement in cadonilimab's global development and a concrete step in Akeso's worldwide strategy, reinforcing its leadership in next-generation immuno-oncology. The company remains committed to its dual-track approach of proprietary development and strategic collaboration, leveraging global resources to accelerate cadonilimab's international availability and expand accessible treatment options for patients worldwide.

Chemotherapy with or without PD-1 inhibitors, such as nivolumab, represents the international standard of care for advanced gastric cancer. However, the disease exhibits significant heterogeneity. While PD-1 treatment in combination with chemotherapy remains an effective treatment in many gastric cancer patients with high PD-L1 expression (CPS >5), its efficacy is markedly limited in gastric cancer patients with low PD-L1 expression (CPS <5) or negative PD-L1 expression (CPS <1). These low and negative PD-L1 patients constitute well more than half of the total gastric cancer patient population.

In 2024, the FDA narrowed the indication for all approved PD-1 inhibitors in the first-line treatment of advanced gastric cancer, restricting their use to PD-L1-positive patients. Authoritative guidelines, including those from the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), also prioritize recommending nivolumab-based regimens for patients with PD-L1 CPS ≥5. This underscores that treating advanced gastric cancer in PD-L1 low-expressing and negative patients has become a globally recognized clinical challenge.

In 2024, based on the COMPASSION-15 study results, cadonilimab in combination with chemotherapy was approved in China for the first-line treatment of gastric cancer, demonstrating benefit across all patient populations, including both PD-L1 positive and negative subgroups.

COMPASSION-15 is the only global Phase III clinical study in first-line advanced gastric cancer to have demonstrated survival benefit across all patient populations, irrespective of PD-L1 expression status. In this trial, patients with low PD-L1 expression and those who were PD-L1-negative accounted for as high as 49.8% and 23% of the enrolled population, respectively, significantly exceeding proportions observed in historical studies of its kind. The robust representation of low and negative PD-L1 patients in the study and the effective treatment of these patients validates cadonilimab's broad-spectrum antitumor efficacy beyond PD-L1 dependency in gastric cancer.

Long-term follow-up data showed that cadonilimab plus chemotherapy significantly reduced the risk of death by 39% in the overall population compared to the control group (OS HR 0.61), regardless of PD-L1 status. In the PD-L1 CPS ≥5 subgroup, the reduction in mortality risk reached 51% (OS HR 0.49). Importantly, even among patients with low PD-L1 expression (CPS <5), a statistically significant 24% reduction in mortality risk was maintained (OS HR 0.76). These results were presented as an oral report at ESMO 2025. Earlier interim analysis data from the COMPASSION-15 study had been released as a prominent oral presentation at AACR 2024, with the full manuscript subsequently published in the Nature Medicine. These results highlight cadonilimab's potential to elevate the current standard of tumor immunotherapy and address clinical challenges unmet by single-target agents.

Forward-Looking Statement of Akeso, Inc.

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.

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 created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company 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, 26 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.

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Source: Akeso, Inc. Related Stocks: HongKong:9926