Actuate Therapeutics Highlights Significant and Sustained Survival Benefit in Key Metastatic Pancreatic Cancer Patient Populations in Phase 2 Elraglusib Trial

- Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone

- Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a 38% reduction in risk of death when treated with elraglusib plus GnP

CHICAGO and FORT WORTH, Texas, June 24, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today highlighted results from a pre-specified subgroup analysis of its Phase 2 (Actuate-1801 Part 3B) trial of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line metastatic pancreatic adenocarcinoma (mPDAC).

Patients treated for at least one complete cycle (4 weeks) of therapy achieved a median overall survival (mOS) of 12.5 months in the elragusib/GnP arm, compared to 8.5 months in the control arm. The analysis showed a 43% reduction in the risk of death relative to control, highlighting the significant potential impact of early disease control by elraglusib. Improved outcomes were reported in the combination versus control arms, respectively: disease control rate (DCR): 53.4% vs 44.8%, overall response rate (ORR): 37.9% vs 29.3%, and median progression-free survival (PFS): 6.9 vs 5.6 months.

Figure 1: Actuate-1801 Part 3B: Kaplan-Meier Estimate for mOS of Patients Receiving At Least One Complete Cycle of Treatment

In patients with liver metastases, treatment with elraglusib led to a 2.5-fold increase in 1-year OS and a 38% reduction in the risk of death compared to control. While the GnP arm showed 0% OS probability at 18 months, patients on elraglusib achieved a survival probability of 13.6% OS at 18 months. Additional efficacy metrics showed improvements as follows: DCR: 36.8% vs 27.9%, ORR: 29.8% vs 19.7%, and PFS: 4.9 vs 3.9.

Additional clinical benefit was observed across other subgroups:

Figure 2: Elraglusib + GnP Data Show OS Benefit Across Key Subgroups

“We are highly encouraged by the significant clinical benefit provided by elraglusib demonstrated in this study,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Patients who received at least one cycle – or 4 weeks – of elraglusib showed a rapid and meaningful survival benefit, including a near doubling of the 1-year overall survival and 43% reduction in the risk of death compared to control. Separately, in the subgroup of patients with liver metastases, a population with historically poor prognosis, we observed a more than 2.5-fold improvement in 1-year OS with a 38% reduction in risk of death. These results underscore the potential of elraglusib to generate rapid and durable benefit in high-risk patients, which could be highly impactful in future development and commercial pathways.”