Business
Adagene Announces First Patient Dosed in Randomized Dose Optimization Cohort of the Phase 2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA® (pembrolizumab) in Microsatellite Stable Colorectal Cancer
Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm Company anticipates trial completion in early 2027, and potential updates in 2026 Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously reported at ASCO 2025, are anticipated in the coming months SAN DIEGO and SUZ
About this update from Merck & Company, Inc.
[{"type":"image","alt":"Adagene Inc.","displaySize":"","headline":null,"caption":"Adagene Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":263,"url":"https://media.zenfs.com/en/globenewswire.com/af1c524f33a5b0ab58b78f30aa6d36d7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pI3DpScLq.GcBgxWGZ9SEw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTM2ODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/af1c524f33a5b0ab58b78f30aa6d36d7","width":300,"height":263}},"lazy":false},{"type":"text","content":"Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA","length":144,"tagName":"p"},{"type":"text","content":"Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm","length":124,"tagName":"p"},{"type":"text","content":"Company anticipates trial completion in early 2027, and potential updates in 2026 ","length":81,"tagName":"p"},{"type":"text","content":"Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously reported at ASCO 2025, are anticipated in the coming months","length":140,"tagName":"p"},{"type":"text","content":"SAN DIEGO and SUZHOU, China, Oct. 31, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the first patient has been dosed in its randomized, open label Phase 2 study of muzastotug in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with microsatellite stable colorectal cancer (MSS CRC) with no liver metastases. The Phase 2 primary endpoint is overall response rate (ORR).","length":590,"tagName":"p"},{"type":"text","content":"“We are pleased that the randomized Phase 2 trial is now underway in order to confirm the preferred dose for Phase 3 in compliance with Project Optimus,” stated Peter Luo, Ph.D., CEO and President of R&D at Adagene. “To date, muzastotug has been safely dosed at 20 mg/kg Q6W, with less than 20% Grade 3 adverse events and no discontinuations, supporting its position as the potential best in class Treg depleting anti-CTLA-4 agent with improved therapeutic window. Our approach was further h...