Akeso initiates Phase III perioperative trial of cadonilimab in colon cancer, advancing a novel bispecific immuno‑oncology candidate toward potential regulatory approval
Executive summary: The first patient received cadonilimab in a Phase III perioperative trial for colon cancer. This advances Akeso’s first‑in‑class PD-1/CTLA-4 bispecific antibody toward potential approval, which could impact the colorectal cancer therapeutic landscape and Akeso’s future revenue.
Who is involved: Akeso, Inc. (9926.HK), clinical trial sites, and participating patients.
Likely next (inference): Continued patient enrollment, interim safety and efficacy review, and potential regulatory filing if primary endpoints are met.
Akeso announced that the first patient has been dosed in a Phase III study (COMPASSION-40/AK104-313) evaluating cadonilimab, its first‑in‑class PD-1/CTLA-4 bispecific antibody, as monotherapy in the perioperative setting for colon cancer. The trial marks a key milestone for the company's oncology pipeline and positions cadonilimab to compete with existing checkpoint inhibitors such as Roche’s Tecentriq, which recently received FDA approval for a similar stage‑III colon‑cancer indication. Success could diversify Akeso’s revenue base and reinforce Hong Kong‑listed biotech’s presence in the global immuno‑oncology market.
What's next — scenarios
Inference: scenarios and probabilities are Beyond's assessment, not reported fact.
Base: Trial meets primary endpoint (55%)
Akeso would proceed to BLA filing with FDA/EMA, potentially launching cadonilimab in colorectal cancer by 2029.
- Positive interim efficacy readout (expected mid‑2027)
- No safety concerns identified by DSMB
- Statistical significance achieved in disease‑free survival
Upside: Early positive interim data (30%)
Accelerated approval pathway could be pursued, shortening time to market and boosting Akeso’s near‑term outlook.
- Interim analysis shows >20% improvement in disease‑free survival vs control
- Regulatory agency grants Fast Track or Breakthrough Therapy designation
- Manufacturing scale‑up completed ahead of schedule
Downside: Futility or safety signal (15%)
Trial may be halted or redesigned, delaying any commercial launch and affecting Akeso’s pipeline valuation.
- Interim futility boundary crossed (e.g., <5% chance of success)
- Emergence of Grade ≥3 immune‑related adverse events exceeding protocol limits
- DSMB recommends trial modification or termination
Timeline
- — First Patient Dosed in Phase III Perioperative Study of Cadonilimab (PD-1/CTLA-4) in Colon Cancer (PR Newswire)
- — FDA approves Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer (GlobeNewswire)
Analysis — what this means
Sectors affected
- Oncology (colorectal cancer therapeutics)
Historical parallels
- FDA approval of Roche’s Tecentriq (atezolizumab) plus chemotherapy for adjuvant stage III colon cancer – announced 9 Oct 2026
Key entities
Sources
- First Patient Dosed in Phase III Perioperative Study of Cadonilimab (PD-1/CTLA-4) in Colon Cancer — PR Newswire
- FDA approves Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer — GlobeNewswire
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