Core Insights - Actuate Therapeutics, Inc. presented topline results from the Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma, demonstrating significant improvements in overall survival [1][2][5] Efficacy - The trial met its primary endpoint, showing a median overall survival (mOS) of 10.1 months for the elraglusib combination group compared to 7.2 months for the control group, with a hazard ratio (HR) of 0.63 and a log-rank p-value of 0.01, indicating a 37% reduction in the risk of death [2][4][5] - The 12-month survival rate for patients receiving elraglusib with GnP was 44.1%, which is double that of the GnP alone group at 22.3% [2][5] - Continued survival benefits were observed at 18 and 24 months, with survival rates of 19.7% vs 4.4% and 13.8% vs 0% for the elraglusib/GnP combination versus GnP alone, respectively [10] - The overall response rate was numerically improved at 29.0% for the elraglusib combination compared to 21.8% for GnP alone [10] Safety Profile - The trial met its primary safety endpoint, with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the elraglusib combination arm being similar to those in the GnP arm, indicating a favorable risk-benefit profile [10] - Most treatment-related adverse events (TRAEs) were Grade 1-2, with transient visual impairments being the most common [10] - Grade 3 or higher neutropenia was observed, but rates of febrile neutropenia and sepsis were similar across both treatment arms [10] Future Plans - Based on the positive clinical results and manageable safety profile, the company plans to engage with the FDA and EMA in the second half of 2025 to discuss a path towards product registration [3][5] - Actuate will host a Key Opinion Leader (KOL) event to discuss the trial results, featuring prominent experts in the field [8]
Actuate Therapeutics Presents Topline Elraglusib Phase 2 Data at ASCO 2025 Annual Meeting: Trial Meets Primary Endpoint of Median Overall Survival and Doubles 1-Year Survival in First-Line Treatment of Metastatic Pancreatic Cancer