CHICAGO and FORT WORTH, Texas – May 31, 2025 – Actuate Therapeutics (ACTU), a clinical-stage biotech company, has unveiled promising results from its Phase 2 trial of elraglusib, an experimental therapy targeting pancreatic cancer. The data, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, shows a significant improvement in overall survival for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The company plans to engage with the FDA in the second half of 2025 to chart a course for product registration.
The study, dubbed Actuate-1801 Part 3B, evaluated elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) against GnP alone. The trial’s primary endpoint—median overall survival (mOS)—was decisively met. Patients receiving the elraglusib combination saw their mOS increase to 10.1 months, up from 7.2 months in the control arm. This translates to a 37% reduction in the risk of death, a statistically significant and clinically meaningful outcome in this challenging cancer.
“Pancreatic cancer continues to represent one of the highest unmet medical needs,” commented Dr. Devalingam Mahalingam, MD, PhD, of Northwestern University Feinberg School of Medicine, and lead principal investigator of the trial. “The addition of elraglusib to the existing chemotherapy backbone… is promising and may represent a meaningful therapeutic advance for patients with pancreatic cancer.”
Notably, the 12-month survival rate was also dramatically improved in the elraglusib arm, doubling from 22.3% in the control group to 44.1%.
“We significantly improved mOS, cut the risk of death by 37%, and doubled the 12-month survival rate,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Based on the clear clinical benefit and well-tolerated safety profile, we intend to engage with the FDA and EMA in the second half of this year to align on a path to registration.”
Efficacy Data Highlights:
- A Kaplan-Meier estimate for mOS (10.1 months vs 7.2 months).
Figure 1: Actuate-1801 Part 3B: Kaplan-Meier Estimate for mOS as of March 27, 2025 (Topline data cut-off).
- Continued survival benefit was observed at eighteen and twenty-four months (survival rates of 19.7% vs 4.4% and 13.8% vs 0% in the elraglusib/GnP combination arm vs the GnP arm, respectively).
- Numerically improved overall response rates (29.0% in the elraglusib/GnP combination arm vs 21.8% in the GnP arm) and improvements in median progression-free survival and median duration of response of 5.6 months vs 5.1 months, and 5.5 months vs 4.0 months in the elraglusib/GnP combination arms vs GnP arms, respectively.
Safety and Biomarker Findings:
- The trial also met its primary safety endpoint. Treatment-emergent adverse events in the elraglusib/GnP combination arm were similar to those observed in the GnP arm, indicating a favorable risk-benefit profile for the elraglusib/GnP combination
- Treatment-related adverse events were mostly Grade 1-2, with transient visual impairments being the most frequent TRAEs observed.
- While Grade 3 or higher neutropenia was observed, similar rates of febrile neutropenia and sepsis were observed in both treatment arms.
- Pre-dose cytokine analysis suggested lower baseline levels of key immune modulators were correlated with improved 1-year survival.
- Increased CD8-positive and granzyme B-positive T cells, increased NK cells, and decreased myeloid-derived suppressor cells were observed in tumor biopsies only from elraglusib-treated patients.
KOL Event
Actuate is hosting a KOL event to review the data at 6:30 PM CDT today, May 31, 2025 featuring a fireside discussion moderated by Daniel Schmitt with KOLs including Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science; Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine; Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center; and Colin Weekes, MD, PhD, Massachusetts General Hospital.
About the Actuate-1801 Part 3B Study
The study is a randomized, controlled Phase 2 trial evaluating elraglusib with GnP versus GnP alone in first-line mPDAC, enrolling a total of 286 patients. The trial’s primary endpoint is median overall survival.
Actuate Therapeutics is a clinical-stage biopharmaceutical company with a focus on difficult-to-treat cancers. Its lead drug, elraglusib, is a GSK-3β inhibitor aiming to disrupt tumor growth and bolster the effectiveness of chemotherapy.
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