- Adagene (ADAG, Financial) has received positive feedback from the FDA for its clinical development plan involving muzastotug (ADG126) in combination with Merck's KEYTRUDA for MSS CRC.
- Phase 2 trial will involve approximately 60 patients with ORR as a primary endpoint, and enrollment is expected to commence in the second half of 2025.
- The FDA approved a dosing strategy involving 10 mg/kg and 20 mg/kg, showing increased ORR from 17% to 29% while maintaining safety levels.
Adagene Inc. (ADAG) announced that it has received a positive endorsement from the United States Food and Drug Administration (FDA) for the clinical development of its anti-CTLA-4 SAFEbody®, muzastotug (ADG126), in combination with Merck's KEYTRUDA. This follows a productive Type B meeting where the FDA agreed on key aspects of the Phase 2 trial design for treating patients with microsatellite stable colorectal cancer (MSS CRC).
The upcoming Phase 2 trial is set to enroll approximately 60 patients, divided into two dosing arms: 10 mg/kg and 20 mg/kg. This decision comes as preliminary data revealed a dose-dependent increase in the overall response rate (ORR) from 17% at the lower dose to 29% at the higher dose, while maintaining a favorable safety profile with Grade 3 treatment-related adverse events (TRAEs) approximately at 20%.
The trial will focus on late-line MSS CRC patients without liver metastases and is scheduled to begin patient enrollment in the second half of 2025. The primary endpoint of the trial will be ORR, and secondary endpoints will assess duration of response, progression-free survival, and overall survival. This alignment marks a significant milestone in advancing towards a potential registrational trial, addressing a critical unmet medical need within this patient population.
