Adagene announces regulatory update on development plan for muzastotug

Adagene (ADAG) announced outcomes from its Type B meeting with the United States Food and Drug Administration. Adagene has received written feedback from the FDA on its clinical development plan to evaluate muzastotug in combination with Merck’s (MRK) anti-PD-1 therapy, KEYTRUDA in patients with microsatellite stable colorectal cancer. Key Outcomes from the FDA Type B Meeting: Patient Population: Future trials will enroll late-line patients with MSS CRC without liver metastases, including those with peritoneal metastasis/involvement. Dose and Regimen: Phase 2 will randomize patients to either 10 mg/kg or 20 mg/kg of ADG126 in combination with pembrolizumab, using an induction-maintenance regimen, without cycle limitations of ADG126. Phase 2 Trial Design: Approximately 30 patients will be enrolled in each arm of the Phase 2 study, without a requirement for an ADG126 monotherapy arm. Phase 3 Trial Design: The FDA agreed with Adagene’s proposed standard-of-care control arm for the Phase 3 clinical trial and confirmed that an ADG126 monotherapy arm is also not required in the pivotal study. Phase 2 Endpoints: The primary endpoint of the Phase 2 trial will be overall response rate. Secondary endpoints include duration of response, progression-free survival, and overall survival. Phase 3 Endpoints: The primary endpoint of the Phase 3 trial will be OS. Secondary endpoints will include PFS, DOR and ORR.