Akeso, Inc. announced the presentation of a real-world study at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), compared compared cadonilimab plus chemotherapy against a PD-1 inhibitor plus chemotherapy for the first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS The study results showed that the cadonilimab regimen, compared to the PD-1 monoclonal antibody regimen, significantly prolonged patients' overall survival (OS) and progression-free survival (PFS). Both OS (HR=0.49, P=0.025) and PFS (HR=0.43, P=0.006) demonstrated statistically significant improvements. The full study has been accepted for publication in the Journal of Gastrointestinal Oncology.
Anti-PD-1 antibodies combined with chemotherapy is the international standard of care for advanced gastric cancer. However, its efficacy is significantly limited in patients with PD-L1-low (CPS < 5) or negative (CPS <1) expression, where these patients constitute nearly half of all advanced gastric cancer cases. As a result, the U.S. Food and Drug Administration (FDA) restricted all approved first-line PD-1 inhibitors for advanced gastric cancer to only PD-L1-positive patients in 2024.
This aligns with recommendations from leading guidelines, such as those of the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), which prioritize PD-1-based regimens for patients with PD-L1 CPS 5. Consequently, PD-L1-low or -negative advanced gastric cancer remains a major unmet clinical need globally due to thelack of effective immunotherapy options. A recent real-world study provides new evidence addressing this challenge. In this retrospective analysis, patients with PD-L 1-low (CPS <5) advanced G/GEJ cancer received first-line therapy with either Cadonilimab plus chemotherapy or a PD- 1 inhibitor plus chemotherapy.
With a median follow-up of 11.0 months as of February 28, 2025, the results showed that the cadonILimab-based regimen achieved statistically significant and clinically meaningful improvements in both PFS and OS compared to the PD-1 inhibitor-based regimen. Akeso is actively advancing several prospective head-to-head Phase III registration studies with cadonilimab, aiming to elevate current standard immunotherapies. Notably, the international multi-center Phase III registration study COMPASSION-37, evaluating cadonilimabplus chemotherapy versus the PD-1 inhibitor nivolumab plus chemotherapy for first-line treatment of advanced gastric cancer, received approval from the U.S. FDA to initiate at the end of 2025.
This milestone marks a new phase in the global development of cadonilimab. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. R 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.
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, autoimmune disease, inflammation, inflammation, metabolic disease and other major diseases and other major diseases. Among them, 26 candidates have entered clinical trials (including them, 26 candidates has entered clinical trials (including 15 bispecific/multispecific/multispe specific diseases. Among them, 26 candidate (including 15 bispecific antibodies and bispecific/multispecific/multiscific/multispecific antibodies and other major diseases.
