Akeso Enrolls First Patient In Phase 3 Cadonilimab Head-To-Head Gastric Cancer Trial

(RTTNews) – Akeso, Inc. (9926.HK), a biopharmaceutical company, announced that it has enrolled the first patient in COMPASSION-37 (AK104-311), a phase 3 trial evaluating Cadonilimab as first-line treatment for patients with HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

COMPASSION-37 is a global, multicenter phase 3 head-to-head trial evaluating cadonilimab in combination with chemotherapy versus chemotherapy with or without nivolumab as first-line treatment for patients with HER2-negative, previously untreated, unresectable or metastatic G/GEJ adenocarcinoma.

Cadonilimab is a PD-1/CTLA-4 bispecific antibody developed by Akeso for cancer immunotherapy.

Notably, the study is designed to further evaluate the efficacy and safety of cadonilimab as first-line therapy for advanced gastric cancer across geographically diverse patient populations, and to investigate whether dual PD-1/CTLA-4 immune checkpoint blockade can further improve outcomes beyond the current standard of care.

Advanced gastric cancer remains heterogeneous, and while chemotherapy with or without PD-1 inhibitors is standard first-line treatment, effective immunotherapy options for patients with PD-L1-low disease remain a significant unmet need, particularly as PD-1 inhibitor use is increasingly guided by PD-L1 expression.

According to the company, in the earlier COMPASSION-15 study, a randomised, double-blind, placebo-controlled phase 3 study that enrolled 610 patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma, cadonilimab plus chemotherapy significantly reduced the risk of death compared with the control group in the overall population, regardless of PD-L1 expression status.

In addition to the COMPASSION-37 study, a phase 2 study of perioperative cadonilimab with neoadjuvant chemotherapy in patients with localised, resectable HER2-negative gastric or gastroesophageal junction (GEJ) tumours is currently enrolling patients in the United States.

Cadonilimab is being evaluated in more than 13 registrational or phase 3 trials worldwide across gastric, liver, lung, cervical and pancreatic cancers, including two international multicenter registrational/phase 3 studies, the company said.

9926.HK has traded between HK$80.200 and HK$156.00 over the last year. The stock closed Friday’s trade at HK$93.55.

9926.HK is currently down 2.14% at HK$91.55.

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