Adagene completes enrolment of 60 patients in Phase 2 muzastotug-pembrolizumab colorectal cancer dose study
The randomised trial in late-line MSS colorectal cancer without liver metastases is intended to select the dose for a Phase 3 programme, with first results due in the first half of 2027.
Adagene announced on 9 November 2026 that it has finished enrolling 60 patients in a randomised Phase 2 dose-optimisation trial of muzastotug (ADG126), a masked anti-CTLA-4 antibody, given with Merck's pembrolizumab (Keytruda).
The study is in late-line microsatellite stable (MSS) colorectal cancer in patients without liver metastases. Participants were randomised 1:1 to one of two dosing regimens, each consisting of an induction phase followed by maintenance.
Adagene expects initial results in the first half of 2027. The data are meant to guide the choice of dose for a Phase 3 trial.
The company also says the US Food and Drug Administration has previously agreed to key elements of the planned Phase 3 design: a standard-of-care control arm, no monotherapy arm, and overall survival as the primary endpoint.
Why it matters
- Enrolment is complete, so the first read-out on dose selection is expected in the first half of 2027, ahead of Phase 3 planning.
- The FDA agreement on Phase 3 design, as described by Adagene, covers the control arm, the absence of a monotherapy arm and an overall survival primary endpoint. This is the company's account, not an FDA statement.
- Regulatory and clinical-development teams tracking anti-CTLA-4 combinations in MSS colorectal cancer should watch how the two regimens compare when the data emerge.
Company's press release (SEC filing): Adagene Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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