On June 1, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU), a clinical-stage biopharmaceutical company focused on developing novel therapies for difficult-to-treat cancers, reported that two presentations were given at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentations featured post-hoc efficacy and biomarker analyses from the randomized Phase 2 study (NCT03678883), along with clinical data from a Phase 2 study conducted at Mass General Brigham Cancer Institute of elraglusib in combination with FOLFIRINOX (FFX) and the TGF-β inhibitor losartan in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The consistency of the survival benefit, the depth and durability of responses, and the favorable safety profile observed across studies with both gemcitabine/Abraxane and FOLFIRINOX continue to underscore the broad clinical promise of elraglusib in combination with established chemotherapy regimens," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "We believe these data further strengthen the positioning of elraglusib as a potentially differentiated backbone therapy and expand future development opportunities in key patient populations across multiple combination settings. The potential to combine with RAS/RAF/MEK inhibitors in patients where those therapies would be appropriate, along with significant survival benefit in patients without those molecular mutations, speaks to the broad therapeutic potential of elraglusib. Looking ahead, the planned addition of our oral formulation should enable broader combination strategies, greater dosing flexibility, and expanded clinical and commercial potential."

Title: Post-hoc efficacy and biomarker analysis of elraglusib plus gemcitabine/nab-paclitaxel versus chemotherapy alone in metastatic pancreatic ductal adenocarcinoma

First Author: Devalingam Mahalingam, MD, PhD, Gastrointestinal Oncologist and Professor of Medicine at Northwestern University Feinberg School of Medicine

A comprehensive post-hoc efficacy and biomarker analysis of the randomized Phase 2 1801 Part 3B study showed that elraglusib plus gemcitabine/nab-paclitaxel (GnP), compared with GnP alone, provided meaningful clinical benefit across multiple patient subgroups in previously untreated mPDAC.

Key Findings from the Analysis

Striking survival advantages of elraglusib/GnP vs GnP alone were observed in patients with wild-type (WT) tumor genomics:
Patients with KRAS WT treated with elraglusib/GnP achieved a mOS of 16.9 vs 10.1 months (p<0.001), a nearly 7-month improvement.
This survival advantage was consistent across key tumor suppressor gene subgroups analyzed:
TP53 WT: 13.4 vs 7.6 months, (p=0.002)
CDKN2A WT: 10.4 vs 7.6 months, (p=0.002)
SMAD4 WT: 10.1 vs 7.1 months, (p=0.003)
Positive OS trends were observed in both the intent-to-treat (ITT) and modified intent-to-treat (mITT) populations treated with elraglusib plus GnP versus GnP alone.
In a landmark analysis of patients completing at least one treatment cycle, mOS was approximately 12.5 months in the elraglusib/GnP arm compared with 8.5 months in the GnP control arm, with a near doubling of the one-year survival rate versus GnP alone.
Exploratory subgroup analyses demonstrated improved OS in patients treated with elraglusib/GnP vs GnP who had:
ECOG performance status of 0 (12.2 vs 8.0 months; p=0.007)
Baseline albumin ≥3 g/dL (10.8 vs 7.6 months; p=0.02)
Baseline CA19-9 <8000 U/mL (12.2 vs 7.8 months; p=0.01)
Lower tumor grade (Grade 1+2, 14.3 vs 7.8 months, p=0.005)
Lower tumor mutational burden, lower circulating tumor DNA (ctDNA) fraction, and lower tumor grade were correlated with improved survival outcomes only in elraglusib/GnP-treated patients, providing a foundation for prospective patient selection in future studies.
Title: A Phase II Study of FOLFIRINOX (FFX) Combined with the Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor Elraglusib (ELRA) and the Transforming Growth
Factor-β (TGF-β) Inhibitor Losartan (LOS) in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

First Author: Priyadarshini Pathak, Mass General Brigham Cancer Institute, Boston, USA

The Phase 2 study evaluated elraglusib in combination with FFX and losartan (LOS) across four treatment arms in a first-line population of patients with mPDAC.

Key Findings

Arms incorporating elraglusib demonstrated meaningful improvement: elraglusib/FFX and elraglusib/FFX+LOS each achieved mOS of 9.8 months and mPFS of 6.0 and 6.5 months, respectively, vs 7.7 months and PFS of 5.1 with FFX alone.
A subset of patients in elraglusib combination arms demonstrated deep and durable responses, with ongoing biomarker analyses evaluating features associated with long-term benefit.
The combination was generally well tolerated. Grade 3 or higher treatment-related adverse events occurred in 34.7% of patients, with the most common being diarrhea, fatigue, hypokalemia, and decreased platelet count, a profile consistent with the known toxicities of FOLFIRINOX, further supporting the tolerability of elraglusib.

(Press release, Actuate Therapeutics, JUN 1, 2026, View Source [SID1234666353])