Adagene Reports Positive Phase 1b/2 Data for Muzastotug in MSS CRC and Announces Incyte Collaboration
Adagene Inc. announced updated interim results from its Phase 1b/2 study of muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody, in combination with Merck's KEYTRUDA for patients with advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases. As of January 24, 2026, the combined 20 mg/kg cohorts (N=26) achieved a confirmed overall response rate (ORR) of 31%, significantly higher than the 13% ORR observed in the 10 mg/kg cohorts (N=39). Median progression-free survival (mPFS) reached 15.4 months in the 20 mg/kg loading dose cohort. Safety data remained favorable with a low 4% discontinuation rate and no Grade 4 or 5 treatment-related adverse events. Additionally, Adagene announced a clinical collaboration with Incyte to evaluate muzastotug in combination with Incyte's TGFΞ²R2 x PD-1 bispecific antibody (INCA33890). Incyte will sponsor and conduct a Phase 1 study expected to begin in 2026. Adagene's ongoing randomized Phase 2 trial for muzastotug is currently enrolling patients, with results expected in the first half of 2027. The FDA has granted Fast Track designation for muzastotug in this indication.