Adagene's ADG126 to be highlighted in two presentations at CSCO Meeting in Jinan, China.

Adagene's ADG126 will be highlighted in two presentations at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China. The presentations will showcase the safety and efficacy of ADG126 in combination with pembrolizumab in advanced MSS CRC, with an objective response rate of ~30% and durable duration of response. The results are expected to translate into overall survival benefit, with a median OS of 19.4 months in the 10 mg/kg cohorts.

Adagene Inc. (Nasdaq: ADAG) has announced that its ADG126 therapy will be featured in two oral presentations at the 2025 Chinese Society of Clinical Oncology (CSCO) Meeting in Jinan, China, from September 10-14. The presentations will highlight ADG126's combination with pembrolizumab in treating microsatellite stable (MSS) colorectal cancer [1].

ADG126, a masked anti-CTLA-4 therapy, has shown promising results in Phase 1b/2 trials, achieving an objective response rate of ~30% with durable response and over 80% disease control in refractory/resistant MSS CRC patients with no liver metastasis. The treatment demonstrated a median overall survival of 19.4 months in the 10 mg/kg cohorts, while maintaining less than 20% Grade 3 treatment-related adverse events [1].

The upcoming presentation of ADG126 data at CSCO represents a significant milestone in immunotherapy for colorectal cancer. The masked anti-CTLA-4 antibody approach is particularly notable because MSS colorectal cancer has historically been considered a "cold tumor" resistant to immunotherapeutic approaches [1].

The reported ~30% objective response rate with durable response duration and 80% disease control in MSS CRC patients without liver metastasis is remarkable compared to historical immunotherapy performance in this population. Traditional immunotherapies typically show minimal effectiveness in MSS CRC, which represents approximately 85% of colorectal cancer cases [1].

Most impressive is the 19.4-month median overall survival demonstrated in the 10 mg/kg cohort. For context, refractory MSS CRC patients typically have survival measured in single-digit months with standard therapies [1].

The safety profile enabling higher, more frequent dosing of anti-CTLA-4 therapy is critical, as traditional CTLA-4 inhibitors like ipilimumab are often limited by toxicity concerns. The reported 20% Grade 3 treatment-related adverse events suggests a meaningful improvement in the therapeutic window [1].

ADG126's mechanism targeting intratumoral Treg depletion addresses a key immunosuppressive barrier in cold tumors. If these results are confirmed in larger studies, this could represent a breakthrough for the substantial population of MSS CRC patients who currently lack effective immunotherapy options [1].

The presentations at CSCO will provide an opportunity for Adagene to share the latest data on ADG126's safety and efficacy in combination with pembrolizumab, further validating its potential as a transformative therapy in the treatment of MSS CRC [1].

References:
[1] https://www.stocktitan.net/news/ADAG/adagene-s-adg126-to-be-highlighted-in-two-presentations-at-the-2025-a0q337c20vcf.html