Akeso Biopharma (HKG: 9926) announced that the U.S. FDA approved cadonilimab in combination with chemotherapy to initiate the international multicenter Phase 3 COMPASSION‑37/AK104‑311 study. The trial will compare cadonilimab plus chemotherapy against chemotherapy with or without nivolumab for first‑line treatment of HER2‑negative unresectable or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma. This marks the second international registration study for cadonilimab.
Study Overview
Parameter
Details
Study Name
COMPASSION‑37/AK104‑311
Phase
Phase 3
Design
International, multicenter, randomized
Population
HER2‑negative, previously untreated unresectable or metastatic G/GEJ adenocarcinoma
Comparator
Chemotherapy ± nivolumab
Primary Endpoint
Overall survival (OS) and progression‑free survival (PFS)
Regulatory Status
FDA cleared to initiate; first patient enrollment expected Q1 2026
Drug Profile
Attribute
Cadonilimab
Mechanism
PD‑1/CTLA‑4 bispecific antibody (BsAb)
Developer
Akeso Biopharma (self‑developed)
Administration
Intravenous infusion
Differentiation
Dual checkpoint blockade in a single molecule
Previous Regulatory Approvals (NMPA)
Date
Indication
June 2022
Recurrent or metastatic cervical cancer post‑platinum chemotherapy
First‑line persistent/recurrent/metastatic cervical cancer ± bevacizumab
Strategic Implications
For Akeso: International validation of cadonilimab’s platform; second global registration study positions drug for potential US/EU submissions; builds on China leadership in bispecific antibodies.
For Gastric Cancer Market: First‑line HER2‑negative G/GEJ represents 90,000+ eligible patients annually in US/EU; cadonilimab’s PD‑1/CTLA‑4 mechanism could differentiate from nivolumab monotherapy.
For Investors: Demonstrates Akeso’s capability to execute global Phase 3 trials, supporting premium valuation of bispecific pipeline; potential for partnering/licensing in ex‑China markets.
Forward‑Looking Statements This brief contains forward‑looking statements regarding COMPASSION‑37 enrollment timelines, regulatory approvals, and market opportunities. Actual results may differ due to competitive dynamics, regulatory feedback, or clinical risks.-Fineline Info & Tech
By Fineline Cube 