Eraglusib Combo Improves Survival in Metastatic Pancreatic Cancer

Elraglusib plus gemcitabine and nab-paclitaxel significantly improved survival as a first-line treatment for metastatic pancreatic cancer in a global phase 2 trial.

Eraglusib in combination with gemcitabine and nab-paclitaxel achieved statistical significance in the first-line treatment of metastatic pancreatic ductal adenocarcinoma, according to data from the part 3B phase 2 Actuate-1801 trial which were shared in a news release from Actuate Therapeutics, Inc.

These topline results showed a statistically significant improvement in overall survival with the eraglusib combination compared with gemcitabine and nab-paclitaxel alone. Moreover, these data also highlight a substantial improvement in the median overall survival benefit for patients receiving the investigate treatment compared with previous results which were shared in December of 2024.

“Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options,” said Daniel Schmitt, president and CEO of Actuate. “There have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade. Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in metastatic pancreatic ductal adenocarcinoma.

“We are incredibly excited to present the topline data at [the 2025 ASCO Meeting]. Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with United States and European Union regulators in the second half of this year to map out the path to advancing elraglusib to new drug application and registration and making the drug available to patients as expeditiously as possible,” Schmitt continued.

The news release goes on to share that these data meet the primary end point of overall survival in the phase 2 trial study and confirmed a significant one-year survival rate. Moreover, the combination of elraglusib with gemcitabine and nab-paclitaxel also demonstrated a favorable risk-benefit profile (balance between efficacy and safety).

Key findings from the study will be shared in an oral presentation at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO). The company has announced its intent to engage with regulatory authorities to advance the development of elraglusib and expedite its path toward potential approval.

The presentation is entitled "Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC)" and will be shared on Saturday, May 31, 2025, at 4:48 PM Central Daylight time. Dr. Devalingam Mahalingam will be presenting these data.

More Information on the Actuate-1801 Part 3B study

The Actuate-1801 Part 3B study is a randomized, controlled phase 2 clinical trial designed to evaluate the efficacy and safety of elraglusib in combination with gemcitabine and nab-paclitaxel compared with gemcitabine and nab-paclitaxel alone for the first-line treatment of metastatic pancreatic ductal adenocarcinoma. A total of 286 patients with previously untreated metastatic disease were enrolled and randomized to receive either the elraglusib combination or gemcitabine and nab-paclitaxel alone. Patients treated with the combination received elraglusib at a dose of 9.3 milligrams per kilogram on day 1 of each week within a 28-day treatment cycle.

In addition to the primary end point of median overall survival, key secondary end points include disease control rate, objective response rate, progression-free survival, and incidence of side effects.

Importantly, elraglusib functions as an inhibitor of glycogen synthase kinase-3 beta (GSK-3β), a protein involved in cancer progression. Inhibition of GSK-3β has the ability to inhibit tumor growth and improve survival. This is done through several mechanisms which include enhancement of chemotherapy activity, activation of innate anti-tumor immunity and regulation of gene expression.

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