Core Insights - Adagene Inc. presented promising clinical data for ADG126, a masked anti-CTLA-4 SAFEbody, in combination with pembrolizumab for patients with metastatic microsatellite-stable colorectal cancer (MSS CRC) at the ESMO Congress [1][2][3] Clinical Efficacy - Confirmed partial responses (PRs) doubled to four, resulting in an overall response rate (ORR) of 24% (4/17) for patients without liver and peritoneal metastases receiving ADG126 at 10 mg/kg every three weeks [1] - Median progression-free survival (PFS) was 8.5 months for patients without liver and peritoneal metastases at the 10 mg/kg dose [1] - Twelve-month overall survival (OS) rates were 74% for patients without liver metastases and 82% for those without liver and peritoneal metastases [1][6] Safety Profile - The safety profile of ADG126 maintained a low incidence of Grade 3 treatment-related adverse events (TRAEs), with only 16% of patients experiencing such events at the 10 mg/kg Q3W dose [1][5] - No dose-limiting toxicities (DLT) or Grade 4 or 5 TRAEs were observed at any dose up to 20 mg/kg Q3W [4] - The discontinuation rate due to adverse events remained low at 8% [5] Future Development - The company plans to evaluate ADG126 at 10- to 20-fold higher doses than ipilimumab in a randomized, registration-oriented clinical program [9] - Initial data from a cohort evaluating a single dose of ADG126 at 20 mg/kg followed by a 10 mg/kg Q3W maintenance dose in combination with pembrolizumab is expected later this year [7] - Comprehensive pharmacokinetic (PK) analyses are being conducted to guide future clinical development and dose selection [8]
Adagene Presents Results at ESMO Congress that Show Best-in-Class Therapeutic Potential for Anti-CTLA-4 SAFEbody® ADG126 (Muzastotug) in Combination with KEYTRUDA® (Pembrolizumab) in Advanced/Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC)