Akeso has commenced a global Phase III clinical trial, with the enrolment of the first patient, to evaluate its bispecific antibody, cadonilimab, in treating advanced gastric cancer.
The study, titled COMPASSION-37 (AK104-311), will compare the antibody combined with chemotherapy against chemotherapy with or without nivolumab.
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It targets patients with HER2-negative, untreated, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma.
The trial aims to assess the safety and efficacy of cadonilimab as a first-line treatment across diverse patient populations worldwide. It also seeks to determine whether the PD-1/CTLA-4 dual immune checkpoint blockade can enhance outcomes beyond current standard therapies.
International investigators, including Dr Yelena Janjigian from Memorial Sloan Kettering Cancer Center, professor Markus Möhler from Germany, and professors Jiafu Ji and Lin Shen from Peking University, will lead the study.
They previously contributed to the CheckMate 649 trial, which demonstrated the clinical value of combining nivolumab with chemotherapy for advanced gastric cancer.
Janjigian said: “Immunotherapy has transformed the treatment of stomach and oesophagus 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.”
A previous study, COMPASSION-15, indicated that combined cadonilimab and chemotherapy could significantly decrease mortality risk across varying PD-L1 expression levels.
In addition to COMPASSION-37, Akeso is advancing its research into earlier-stage gastric cancer. An international study, spearheaded by Dr Janjigian, is investigating cadonilimab with FLOT chemotherapy in a perioperative context for locally advanced, resectable cases.
Cadonilimab, developed for cancer immunotherapy, gained marketing approval from China’s National Medical Products Administration (NMPA) in June 2022 for certain cervical cancer treatments.
In May 2025, cadonilimab plus platinum-based chemotherapy, with or without bevacizumab, received approval to treat persistent, recurrent, or metastatic cervical cancer.
Recently, Akeso has received clearance from the Center for Drug Evaluation (CDE) under NMPA to begin a Phase I trial of AK158D1, an investigational bispecific antibody-drug conjugate (ADC), for patients with advanced malignant solid tumours.
