Akeso initiates first patient enrollment in global Phase III trial comparing its PD-1/LAG-3 bispecific cadonilimab to nivolumab for first-line gastric cancer
Executive summary: Akeso announced that the first patient has been enrolled in the COMPASSION-37 trial, a global Phase III study comparing its PD-1/LAG-3 bispecific antibody cadonilimab with nivolumab as first-line therapy for gastric cancer. The trial could establish a new first-line immunotherapy option, validate Akeso’s bispecific antibody approach, and impact the market dynamics of gastric cancer treatments.
Who is involved: Akeso, Inc. (9926.HK) as sponsor; clinical sites worldwide; comparator nivolumab (bristol‑myers squibb).
Likely next (inference): Continued patient enrollment with an interim efficacy readout expected within the next 12‑18 months, followed by potential regulatory submissions if efficacy and safety targets are met.
Akeso dosed the first patient in COMPASSION-37, a multicenter Phase III study that will evaluate its investigational cadonilimab against the established PD-1 inhibitor nivolumab in previously untreated gastric cancer. The trial represents a key milestone for Akeso’s bispecific antibody platform and could shape the competitive landscape of first-line gastric immunotherapy. Success would provide a new treatment option and potentially alter market shares, while failure could delay the company’s oncology pipeline.
What's next — scenarios
Inference: scenarios and probabilities are Beyond's assessment, not reported fact.
Base: Trial meets primary endpoint, leading to BLA filing (50%)
Akeso would file a biologics license application for cadonilimab in gastric cancer, opening a new revenue stream.
- Primary endpoint progression‑free survival meets prespecified threshold
- No unexpected safety signals emerge
Upside: Strong superiority over nivolumab accelerates approval (30%)
Clear superiority could lead to accelerated approval and rapid market share gain in first‑line gastric cancer.
- Interim analysis shows hazard ratio <0.8 for PFS
- Positive overall survival trend at interim
Downside: Trial fails to show superiority or safety concerns (20%)
Lack of efficacy or safety issues would delay development and potentially require trial redesign.
- Interim futility crossing
- Grade 3+ adverse events exceeding comparator
Timeline
- — Akeso Announces First Patient Enrolled in Global Phase III Trial of Cadonilimab Versus Nivolumab in First-Line Gastric Cancer (PR Newswire)
Analysis — what this means
Sectors affected
- gastric cancer immunotherapy
- PD-1/LAG-3 bispecific antibody therapeutics
Regulatory implications
- FDA oversight of Phase III trial; potential BLA submission upon success
- EMA review if pursued in the EU
Historical parallels
- Pembrolizumab (Keytruda) first‑line approval for gastric cancer 2017
- Nivolumab (Opdivo) approval for gastric cancer 2020
Key entities
Sources
- Akeso Announces First Patient Enrolled in Global Phase III Trial of Cadonilimab Versus Nivolumab in First-Line Gastric Cancer — PR Newswire
Related cases
- FDA’s approval of Roche’s Tecentriq for adjuvant colon cancer expands immunotherapy options and promises a new revenue stream for the drug
- Tallinn harbour’s Q3 2026 cargo volumes slipped while passenger traffic rose modestly, highlighting divergent freight and travel trends
- TextMagic posts 12% YoY revenue growth in Q3 2026, reaching €3.6 million
- XTEND advances to Phase III of U.S. SOCOM modular drone program, reinforcing its position in the drone dominance market
- Akeso secures major clinical spotlight at ESMO 2026 with breakthrough Phase III biliary tract cancer survival data
- Antengene initiates pivotal Phase III CLINCH-3 trial of ATG-022, advancing its oncology pipeline