Actuate Therapeutics shares highlights from KOL eventon elraglusib data

Actuate Therapeutics (ACTU) announced key takeaways from its Key Opinion Leader event held on May 31, 2025 discussing the topline results from the Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. The study met its primary endpoint, demonstrating a clinically meaningful increase in median overall survival of 10.1 months compared to 7.2 months, with a 37% reduction in the risk of death. The elraglusib/GnP arm also doubled the 12-month survival rate in 44.1% of patients compared to GnP alone, with a favorable safety profile. The KOL event followed the presentation of topline trial data during an oral session at the American Society of Clinical Oncology Annual Meeting. The event featured a fireside discussion with leading mPDAC clinicians, all with direct participation in the elraglusib clinical trial program: Colin Weekes, MD, PhD, Massachusetts General Hospital; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science. The panelists highlighted the implications of the Phase 2 Actuate 1801 Part 3B results in the broader context of the unmet need in mPDAC, the unique immune-modulating mechanism of elraglusib, and its potential to reshape the treatment landscape. Daniel Schmitt, CEO of Actuate said, “The reception we received at ASCO confirms what we already believed – this data has the potential to change the trajectory of mPDAC treatment. As our KOLs highlighted in the panel discussion, there is a clear need for new drugs, like elraglusib, with new mechanistic pathways, and which can be successfully combined without overlapping toxicities for treatment of this devastating disease. As these thought leaders pointed out, due to a number of negative trials, there has been quite some time since we’ve had anything that improves outcomes for patients with these chemotherapy backbones. The thought leaders further highlighted the importance of the overall survival benefit and noted the magnitude of that benefit in the elraglusib trial is actually substantial. We are now laser-focused on turning this promise into patient access. With a clear survival benefit, favorable safety profile, and strong scientific rationale, we look forward to advancing elraglusib development and initiating regulatory discussions with both the FDA and EMA.”