Adagene completes enrollment in Phase 2 muzastotug dose-optimization trial for MSS colorectal cancer
Adagene finished enrolling 60 patients in a randomized Phase 2 trial testing muzastotug with Merck's Keytruda, with initial data expected in the first half of 2027.
Adagene's main update this week concerns its lead program in colorectal cancer.
- Adagene completed enrollment in a randomized Phase 2 dose-optimization trial testing muzastotug (ADG126) alongside Merck's pembrolizumab (KEYTRUDA) in patients with late-line microsatellite stable colorectal cancer without liver metastases.1 The company said enrollment totaled 60 patients, with initial results expected in the first half of 2027 to help determine the dose regimen for an upcoming Phase 3 trial.1
- The trial, registered as "NCT05405595," was added into the existing protocol for the ongoing Phase 1b/2 study after a 2025 meeting with the FDA.1 Patients were split evenly between two treatment groups testing different muzastotug dosing schedules in combination with pembrolizumab.1 The trial's primary endpoint is overall response rate, with duration of response, progression-free survival, and overall survival as secondary endpoints.1
- For the planned Phase 3 trial, Adagene said the FDA agreed to a standard-of-care control arm and confirmed that a muzastotug monotherapy arm would not be required.1 The Phase 3 trial's primary endpoint will be overall survival, with progression-free survival, duration of response, and overall response rate as secondary endpoints.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.