Actuate Therapeutics, Inc. (ACTU) reported encouraging subgroup results Tuesday from its ongoing Phase 2 trial evaluating elraglusib in combination with gemcitabine/nab-paclitaxel or GnP for first-line treatment of metastatic pancreatic ductal adenocarcinoma or mPDAC.
The Actuate-1801 Part 3B trial showed that patients receiving at least one cycle or 4 weeks of elraglusib plus GnP experienced a median overall survival or mOS of 12.5 months compared to 8.5 months for patients on GnP alone, with a 43% reduction in risk of death.
The combination also demonstrated improved secondary outcomes, including a disease control rate of 53.4% vs 44.8%, an overall response rate of 37.9% vs 29.3%, and median progression-free survival of 6.9 vs 5.6 months, favoring the elraglusib arm.
In a high-risk subgroup of patients with liver metastases, the trial reported a 2.5-fold increase in 1-year overall survival and a 38% reduction in risk of death compared to standard GnP treatment.
Elraglusib is a novel oral inhibitor of glycogen synthase kinase-3 beta (GSK-3ß), a target implicated in tumor growth, chemotherapy resistance, and immune evasion. The drug may also enhance anti-tumor immune activity by modulating immune checkpoints and DNA damage response pathways.
Actuate CEO Daniel Schmitt noted the rapid and durable clinical benefit observed, especially in patients with liver metastases, who typically face poor prognoses. The company plans to explore further development pathways and future regulatory discussions.
Metastatic pancreatic cancer remains among the deadliest malignancies, with a 5-year survival rate of just 3-5%. Elraglusib may represent a new treatment option for these patients if future trials confirm the Phase 2 findings.
Currently, ACTU is trading at $6.88, down by 2.33 percent on the Nasdaq.
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