{"id":1018653,"date":"2026-11-09T07:36:34","date_gmt":"2026-11-09T12:36:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/adagene-announces-completion-of-enrollment-in-randomized-dose-optimization-phase-2-trial-of-muzastotug-in-combination-with-keytruda-pembrolizumab-in-microsatellite-stable-colorectal-cancer\/"},"modified":"2026-11-09T07:36:34","modified_gmt":"2026-11-09T12:36:34","slug":"adagene-announces-completion-of-enrollment-in-randomized-dose-optimization-phase-2-trial-of-muzastotug-in-combination-with-keytruda-pembrolizumab-in-microsatellite-stable-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/adagene-announces-completion-of-enrollment-in-randomized-dose-optimization-phase-2-trial-of-muzastotug-in-combination-with-keytruda-pembrolizumab-in-microsatellite-stable-colorectal-cancer\/","title":{"rendered":"Adagene Announces Completion of Enrollment in Randomized Dose Optimization Phase 2 Trial of Muzastotug in Combination with KEYTRUDA\u00ae (pembrolizumab) in Microsatellite Stable Colorectal Cancer"},"content":{"rendered":"
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\n – Enrollment of 60 patients complete; initial results expected in 1H 2027 to inform dose regimen for the Phase 3 trial<\/em>
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\n – Adagene continues to own worldwide commercial rights to muzastotug<\/em>\n <\/p>\n

SAN DIEGO and SUZHOU, China, Nov. 09, 2026 (GLOBE NEWSWIRE) — Adagene Inc. (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced completion of enrollment in its randomized Phase 2 dose-optimization trial of muzastotug (ADG126), a masked, anti-CTLA-4 SAFEbody\u00ae<\/sup>, in combination with Merck\u2019s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA\u00ae<\/sup> (pembrolizumab), in patients with late-line microsatellite stable colorectal cancer (MSS CRC) without liver metastases.<\/p>\n

\u201cCompleting enrollment in this randomized trial is an important step toward identifying the dose regimen of muzastotug for the Phase 3 registration trial,\u201d said Peter Luo, Ph.D., Chairman and President of R&D at Adagene. \u201cWe acknowledge Sanofi\u2019s additional equity investment associated with this trial, which supports continued development of muzastotug in solid tumors, including MSS CRC, where dose-limiting challenges have restricted the use of anti-CTLA-4 therapies. As we look ahead to initial results in the first half of 2027, we hope new data will validate muzastotug\u2019s broad applicability and combinability, further enhanced by its induction and maintenance dosing regimens. This could position muzastotug as a transformative next-generation backbone for combination therapies across multiple indications, in both early- and late-line treatment settings. It could also unlock value in indications where legacy CTLA-4\/PD-1 based combinations are already FDA-approved, as well as in historically refractory tumors like MSS CRC.\u201d<\/p>\n

\n About the Phase 2 Trial
<\/strong>The randomized Phase 2 trial (NCT05405595) was incorporated into the existing protocol for the Phase 1b\/2 study following a 2025 meeting with the U.S. Food and Drug Administration (FDA). The primary endpoint of the Phase 2 trial is overall response rate (ORR), and secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS).<\/p>\n

The study enrolled 60 patients, randomized 1:1 into one of two treatment arms evaluating different dose regimens of muzastotug in combination with pembrolizumab. Both arms use induction to rapidly establish activated muzastotug exposure in tumors, followed by maintenance to sustain exposure and potentially improve ORR and OS:<\/p>\n