Akeso has launched COMPASSION-37 (AK104-311), a global Phase III trial testing cadonilimab plus chemotherapy versus chemotherapy with or without nivolumab as first-line therapy for HER2-negative advanced gastric and gastroesophageal junction adenocarcinoma. The study will evaluate safety and efficacy of PD-1/CTLA-4 dual blockade across diverse populations, following encouraging signals from COMPASSION-15. Leading international investigators will spearhead the trial, while Akeso advances related perioperative studies and a Phase I ADC programme.
Akeso Launches Global Phase III Trial of Cadonilimab in First-Line Advanced Gastric Cancer
The bispecific antibody is intended for treating advanced gastric cancer. Credit: SewCreamStudio/Shutterstock.com.
Akeso has enrolled the first patient in COMPASSION-37 (AK104-311), a global Phase III trial evaluating cadonilimab — the company's PD-1/CTLA-4 bispecific antibody — combined with chemotherapy as a first-line treatment for HER2-negative, untreated, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma.
Study Design and Objectives
COMPASSION-37 will compare three treatment strategies: cadonilimab plus chemotherapy, chemotherapy alone, and chemotherapy combined with nivolumab. The trial aims to assess the safety and efficacy of cadonilimab across diverse patient populations worldwide and to determine whether dual immune checkpoint blockade of PD-1 and CTLA-4 can improve outcomes beyond current standard regimens.
Who Is Leading the Trial
The programme is led by an international team of investigators, including Dr Yelena Janjigian (Memorial Sloan Kettering Cancer Center), Professor Markus Möhler (Germany), and Professors Jiafu Ji and Lin Shen (Peking University). Several participating clinicians also contributed to CheckMate 649, the landmark trial that showed benefit from adding nivolumab to chemotherapy in advanced gastric cancer.
Dr Yelena Janjigian: "Immunotherapy has transformed the treatment of stomach and esophageal cancers, helping patients live longer and better. Through our evaluation of cadonilimab as a potential first-line treatment for advanced disease, we aim to better understand its potential to improve outcomes and support longer-term survival for patients."
Supporting Data and Related Programmes
Earlier results from COMPASSION-15 suggested that cadonilimab combined with chemotherapy may reduce mortality risk across a range of PD-L1 expression levels, providing rationale for this registrational Phase III study. Akeso is also expanding cadonilimab research into earlier-stage disease: an international perioperative trial led by Dr Janjigian is testing cadonilimab with FLOT chemotherapy for locally advanced, resectable gastric cancer.
Regulatory Status and Pipeline Updates
Cadonilimab received approval from China’s National Medical Products Administration (NMPA) in June 2022 for certain cervical cancer indications, and in May 2025 the indication was expanded to include cadonilimab plus platinum-based chemotherapy, with or without bevacizumab, for persistent, recurrent, or metastatic cervical cancer. Separately, Akeso recently received clearance from the Center for Drug Evaluation (CDE) under the NMPA to initiate a Phase I trial of AK158D1, an investigational bispecific antibody-drug conjugate (ADC) for advanced solid tumours.
Note: The original report was published by Clinical Trials Arena, a GlobalData brand.
Help us improve.
