Core Insights - Actuate Therapeutics announced positive interim data from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for treating metastatic pancreatic ductal adenocarcinoma (mPDAC) [1][2][3] Summary by Sections Trial Results - The trial met its primary endpoint with a 1-year survival rate of 43.6% in the elraglusib-GnP combination arm compared to 22.5% in the GnP control arm (p=0.002) [4] - Median overall survival (mOS) was 9.3 months for the elraglusib-GnP arm versus 7.2 months for the GnP arm, indicating a 37% reduction in risk of death (HR=0.63, p=0.016) [4] - Objective Response Rates (ORR) were 27.7% in the elraglusib-GnP arm compared to 20.5% in the GnP arm, while Disease Control Rates (DCR) were 42.6% versus 33.3% respectively [4] Patient Outcomes - As of the data cutoff on November 15, 2024, 38% of patients in the elraglusib-GnP arm were still alive compared to 19% in the control arm [4] - Notable patient outcomes included two patients with previously inoperable metastatic lesions showing significant reductions in target lesions, with one achieving a 100% reduction in total tumor burden after surgery [4] Safety Profile - The trial met its primary safety endpoint, with treatment-emergent adverse events (TEAEs) and Serious Adverse Events (SAEs) in the elraglusib-GnP arm being similar to those in the GnP arm, indicating a favorable risk-benefit profile [4][5] Future Plans - The company plans to engage with the FDA in the first half of 2025 to share topline data and discuss next steps, including a proposed Phase 3 registration trial [3][5]
Actuate Therapeutics Announces Positive Interim Phase 2 Data of Elraglusib in First Line Treatment of Metastatic Pancreatic Cancer