Actuate, Incyte, University of Pittsburgh collaborate on elraglusib trial

Actuate Therapeutics (ACTU) announced the initiation of the Phase 1b trial of elraglusib in combination with Incyte’s (INCY) PD-1 inhibitor, retifanlimab, and modified FOLFIRINOX as frontline therapy in advanced pancreatic adenocarcinoma. The trial is being conducted in collaboration with UPMC Hillman Cancer Center and Incyte Corporation. The Investigator-Initiated Phase 1b open-label, single-arm RiLEY trial, led by Anwaar Saeed, MD, Associate Professor of Medicine, and Chief of the Gastrointestinal Medical Oncology at UPMC Hillman Cancer Center, will initially enroll up to 12 patients with advanced pancreatic adenocarcinoma with an expansion plan based on interim efficacy results. The primary objective of the trial is to determine the recommended phase 2 dose for the combination regimen, while the secondary objectives include evaluation of overall response rate, disease control rate, median progression-free survival, overall survival, and assessment of safety and tolerability. In a recent Phase 2 study, elraglusib in combination with gemcitabine/nab-paclitaxel in first-line metastatic pancreatic adenocarcinoma met its primary endpoint, showing a significant increase in median overall survival, a 37% reduction in the risk of death, and a doubling of the 12-month survival rate. In addition, 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, demonstrating elraglusib’s proposed immune modulating mechanism of action in patients with mPDAC. In addition, elraglusib is being studied in a separate investigator initiated Phase 2 trial in combination with FOLFIRINOX and losartan in treatment-naive mPDAC patients. Initial data from this Phase 2 trial, which were presented at the American Association for Cancer Research Special Conference on Advances in Pancreatic Cancer Research last September, showed patients with extensive liver metastases experienced deep, durable responses to the novel combination treatment. Additional results from that study are expected in 2026.