Adagene Inc. announced positive updated clinical data for ADG126 (muzastotug), an anti-CTLA-4 SAFEbody® drug, combined with pembrolizumab in a Phase 1b/2 trial for microsatellite stable colorectal cancer (MSS CRC). The combination therapy demonstrated a 33% overall response rate in twelve patients receiving a 20 mg/kg loading dose followed by 10 mg/kg every three weeks, with no Grade 4/5 treatment-related adverse events or discontinuations. The study focuses on MSS CRC, a challenging cancer type with limited treatment options.
This news is particularly encouraging because MSS CRC is notoriously resistant to current immunotherapies. The 33% overall response rate observed with ADG126 plus pembrolizumab suggests a potential breakthrough for this patient population. The manageable safety profile, with no high-grade adverse events or discontinuations, further enhances the drug’s potential as a viable treatment option. This progress could lead to a much-needed new therapy for a cancer with a historically poor prognosis.
The technical highlight of this update is the improved overall response rate achieved with the loading dose regimen of ADG126. The previously reported overall response rate at a consistent 10 mg/kg dose was 23%. The increase to 33% with the loading dose suggests a potential benefit from achieving higher initial drug concentrations. Importantly, all responders remained on treatment at the time of the announcement. Adagene plans to expand the study to include patients with liver metastases and explore standard-of-care combinations, indicating confidence in ADG126’s therapeutic index. The most common treatment-related adverse event was pruritus (25%), and higher-grade adverse events were managed with dose modifications and limited medical interventions.
This positive data reinforces ADG126’s potential as a best-in-class CTLA-4 inhibitor. The results warrant continued development and could lead to a new therapeutic option for MSS CRC patients, a population with significant unmet medical needs. The planned expansion of the trial, including patients with liver metastases, will provide further insights into ADG126’s efficacy and safety profile in a broader patient population and potentially establish it as a key component in combination therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
