Masked anti-CTLA-4 posts 29–40% ORR in immune-cold MSS CRC; Phase 3 dose selection is the pivot point

Adagene is a clinical-stage company developing a targeted cancer drug for colorectal cancer that is not yet approved.

Muzastotug (ADG126), a masked anti-CTLA-4 antibody, has produced 29–40% confirmed ORR with a 19.4-month median OS and no Grade 4-5 TRAEs in MSS colorectal cancer, a disease historically unresponsive to checkpoint blockade. The thesis holds if the randomized Phase 2 dose-optimization study selects a regimen that FDA accepts as the basis for a Phase 3 registration trial in this indication. The primary risk is that single-arm Phase 1b data, however promising, may not translate to a randomized setting where the optimal dose and combination partner remain unconfirmed.