Actuate Therapeutics, Inc. (NASDAQ:ACTU) has announced breakthrough results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The study, presented at the ASCO Annual Meeting, met its primary endpoint by significantly extending median overall survival to 10.1 months versus 7.2 months for standard GnP alone. This translates to a 37% reduction in the risk of death (HR=0.63, p=0.01).
A healthcare professional wearing a health communications device discussing patient data with a colleague.
Notably, the 12-month survival rate doubled to 44.1% with the elraglusib combination compared to 22.3% for GnP alone, marking a clinically meaningful advance for a cancer with few recent treatment breakthroughs. The safety profile was favorable, with most side effects being mild and manageable. Actuate Therapeutics, Inc. plans to engage with the FDA later this year to discuss the path to registration, aiming to bring this first-in-class GSK-3β inhibitor therapy to patients with urgent unmet needs.
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