Adagene Inc. announced on July 15, 2025, that it received written feedback from the United States Food and Drug Administration (FDA) following a productive Type B meeting. The FDA provided endorsement for Adagene's clinical development plan to evaluate muzastotug (ADG126) in combination with KEYTRUDA® (pembrolizumab) in patients with microsatellite stable colorectal cancer (MSS CRC). This alignment covers Phase 2 inclusion/exclusion criteria, primary and secondary endpoints, and study design, including sample size and dosing regimen.
A key outcome of the meeting was the FDA's endorsement to explore ADG126 at doses 10 to 20 times higher than other anti-CTLA-4 antibodies, without limitations on treatment cycles. This decision is supported by Phase 1b/2 data showing a nearly two-fold increase in overall response rate (ORR) from 17% at 10 mg/kg to 29% at 20 mg/kg, while Grade 3 treatment-related adverse events (TRAEs) remained approximately 20%. These results highlight the wide therapeutic index and favorable safety profile of ADG126.
Adagene expects to begin enrolling patients in the Phase 2 trial in the second half of 2025. This Phase 2 trial is designed to identify the optimal dose for a subsequent Phase 3 trial, marking a critical step towards potential registrational approval. The FDA's endorsement provides a clear regulatory pathway and validates the robust dose-dependent efficacy data and potential best-in-class safety profile of ADG126.
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