Adagene Inc. released updated Phase 1b/2 clinical trial data for ADG126, a novel anti-CTLA-4 antibody, combined with pembrolizumab in patients with advanced microsatellite stable colorectal cancer (MSS CRC) without liver metastases. The 20 mg/kg dose of ADG126 administered every six weeks demonstrated a 29% confirmed overall response rate (ORR) with less than 20% Grade 3 adverse events. Notably, all responders in the 20 mg/kg cohorts remain on treatment, some for over forty weeks.

This updated data holds significant promise for MSS CRC patients, a population with historically limited treatment options. The sustained responses and reduced toxicity profile observed with the 20 mg/kg Q6W dosing regimen suggest the potential for improved long-term outcomes compared to current standards of care. Furthermore, the absence of discontinuations due to adverse events in the 20 mg/kg cohorts underscores the improved tolerability of ADG126 compared to traditional CTLA-4 inhibitors, which are often hampered by significant toxicity. This could translate to a better quality of life for patients undergoing treatment.

The 10 mg/kg cohorts showed a 17% ORR and a median overall survival of 19.4 months. While both 20 mg/kg cohorts achieved a 29% ORR, the every-six-weeks dosing regimen yielded a superior safety profile compared to the other 20 mg/kg regimen involving a loading dose followed by a lower maintenance dose. The median duration of response for the 20 mg/kg cohorts was not yet reached, and all responses are ongoing, highlighting the durability of treatment response.

As further data from the 20 mg/kg cohorts mature, Adagene plans to engage with regulatory authorities to determine the appropriate dosing regimen for the next phase of clinical development. This could pave the way for a new treatment option for MSS CRC, potentially offering improved efficacy and safety for patients. The continued development of ADG126 represents a step forward in the field of cancer immunotherapy, particularly for this challenging cancer type.

Source link: https://www.globenewswire.com/news-release/2025/05/22/3087160/0/en/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-Oncolo.html

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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.