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Rhea-AI Impact(Moderate)Rhea-AI Sentiment(Very Positive)TagsRhea-AI SummaryPositiveDoubled confirmed partial responses to four in MSS CRC patients without liver and peritoneal metastases24% overall response rate (ORR) with ADG126 10 mg/kg Q3W in combination with pembrolizumabMedian progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases12-month overall survival rates of 74% for patients without liver metastases and 82% for those without liver and peritoneal metastasesLow rate of Grade 3 TRAEs (16%) in patients treated with ADG126 10 mg/kg Q3W in combination with pembrolizumabNo dose-limiting toxicities or Grade 4/5 TRAEs observed at any dose up to 20 mg/kg Q3WOverall disease control rate of 88% in patients without liver and peritoneal metastasesNegativeefficacy in patients with liver metastasesSeven patients developed treatment-related serious adverse events8% discontinuation rate due to adverse events

Adagene Inc. (Nasdaq: ADAG) presented promising results for its anti-CTLA-4 SAFEbody® ADG126 (Muzastotug) in combination with KEYTRUDA® (Pembrolizumab) at the ESMO Congress. The phase 1b/2 trial focused on advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) patients. Key findings include:

1. Doubled confirmed partial responses to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases, with a 24% overall response rate.

2. Median progression-free survival of 8.5 months in patients without liver and peritoneal metastases at ADG126 10 mg/kg Q3W dose.

3. 12-month overall survival rates of 74% for patients without liver metastases and 82% for those without liver and peritoneal metastases at 10 mg/kg dose.

4. Maintained safety profile with only 16% Grade 3 TRAEs in patients treated with ADG126 10 mg/kg Q3W combined with pembrolizumab.

- Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) of 24% (4/17) with ADG126 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab -

- Median progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases at the ADG126 10 mg/kg Q3W dose -

- At the 10 mg/kg dose level, 12-month overall survival (OS) rates were 74% for patients without liver metastases, and 82% for those without liver and peritoneal metastases -

- Safety profile maintained, with only 16% Grade 3 TRAEs in patients treated with ADG126 10 mg/kg Q3W in combination with pembrolizumab -

- Combination shows potential with standard of care to address broader patient populations, including MSS CRC patients with liver metastases -

SAN DIEGO and SUZHOU, China, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced new ADG126 clinical data presented at the ESMO Congress, taking place in Barcelona, Spain, September 13-17.

“I am delighted that the ESMO data show a promising overall response rate, progression-free survival (PFS) and early survival benefit from treatment with the immunotherapy (IO) doublet of ADG126 in combination with pembrolizumab for patients with advanced/metastatic MSS CRC, the largest segment of colorectal cancer with few treatment options,” said Daneng Li, MD, Associate Professor in the Department of Medical Oncology & Therapeutics Research at the City of Hope Comprehensive Cancer Center, and a study investigator. “With a much higher dosing level than available anti-CTLA-4 therapies, these data reinforce the encouraging safety and efficacy profile for ADG126 administered repeatedly in MSS CRC.”