Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA® (pembrolizumab) in Colorectal Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting

CTLA-4 inhibitor ADG126 can be dosed at 20 mg/kg Q6W in combination with pembrolizumab with <20% Grade 3 adverse events

In combination with pembrolizumab, ADG126 showed a 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer

All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks

Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months and only 1 out of 41 patients was censored due to early withdrawal within the first 12 months

Excerpt from the Press Release:

SAN DIEGO and SUZHOU, China, May 22, 2025 (GLOBE NEWSWIRE) — Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases at ASCO.

Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope added, “The 20 mg/kg Q6W dose has demonstrated a significant reduction in treatment-related toxicities – with fewer than 20% Grade 3 adverse events and no discontinuations – while maintaining a near 30% ORR, including in patients with peritoneal involvement. Notably, responders in the 20 mg/kg cohorts remain on treatment, supported by tumor assessments, CEA levels, and ctDNA biomarkers.” Dr. Fakih continued, “It is exciting to see the higher ORR and durable responses. There is also early separation shown on the Kaplan-Meier overall survival curves when compared to historical controls. These data are consistent with the more mature overall survival seen in the 10 mg/kg cohorts.”

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