Actuate Therapeutics’ Pancreatic Cancer Drug Elraglusib Shows Survival Benefit in Phase 2 Study
Actuate Therapeutics reported positive topline results from the Phase 2 (Actuate-1801 Part 3B) trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) patients.
The trial met its primary endpoint, showing a clinically meaningful increase in median overall survival:
10.1 months for elraglusib/GnP versus 7.2 months for GnP alone, a 3-month improvement (p=0.01).
Risk of death was reduced by 37% in patients receiving elraglusib/GnP (hazard ratio 0.63).
The 12-month survival rate doubled from 22.3% in the GnP-alone group to 44.1% in the elraglusib/GnP group, indicating improved longer-term survival.
The data were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and discussed further in a Key Opinion Leader event.
Actuate Therapeutics plans to engage with the FDA in the second half of 2025 to pursue product registration based on these results.
Elraglusib works through inhibition of glycogen synthase kinase-3 beta (GSK-3β), targeting difficult-to-treat cancers including pancreatic cancer.
The combination treatment was reported to have a favorable safety profile in the study population.