Adagene Inc. announced updated data from its Phase 1b/2 study of muzastotug (ADG126) in advanced microsatellite stable colorectal cancer (MSS CRC) at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 22, 2025. The data showed that ADG126, when dosed at 20 mg/kg every six weeks in combination with pembrolizumab, resulted in less than 20% Grade 3 adverse events, demonstrating a significant reduction in treatment-related toxicities.
The study reported a 29% confirmed overall response rate (ORR) in MSS CRC patients treated with ADG126 in combination with pembrolizumab. All six responders in the 20 mg/kg cohorts remained on treatment, with four patients continuing on study for over forty weeks, indicating durable responses. The median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months, comparing favorably with current standard of care treatments.
Adagene's CEO and President of R&D, Peter Luo, Ph.D., emphasized that the masking technology reduces toxicity, allowing patients to remain on treatment longer for sustained benefit. The company plans to discuss dosing regimens with regulatory bodies to guide the next phase of clinical development, building on the robust efficacy and best-in-class safety profile observed.
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