Core Insights - Actuate Therapeutics announced positive topline results from the Phase 2 trial of elraglusib in combination with gemcitabine/nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma, indicating a significant improvement in overall survival [1][2][5] Study Results - The study achieved its primary endpoint with a median overall survival of 10.1 months for the elraglusib/GnP group compared to 7.2 months for the GnP group, resulting in a 37% reduction in the risk of death (HR = 0.63) [2][8] - The 12-month survival rate was 44.1% in the elraglusib/GnP arm versus 22.3% in the GnP arm, demonstrating a doubling of survival rates [2][8] - 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 elraglusib/GnP compared to GnP alone, respectively [8] - The overall response rate was numerically improved at 29.0% for the elraglusib/GnP arm compared to 21.8% for the GnP arm [8] 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 [8] - Most treatment-related adverse events (TRAEs) were Grade 1-2, with transient visual impairments being the most common [8] Mechanism of Action - Elraglusib works by inhibiting GSK-3β, which may enhance chemotherapy activity, activate anti-tumor immunity, and regulate gene expression, potentially leading to improved survival outcomes [10][11] Clinical Context - The KOL event highlighted the unmet need in mPDAC and the potential of elraglusib to reshape treatment paradigms, emphasizing the importance of new drugs with unique mechanisms [4][5]

Core Insights - Actuate Therapeutics, Inc. announced the acceptance of an abstract for an oral presentation at the 2025 ASCO Annual Meeting, focusing on the Phase 2 trial data of elraglusib in combination with GnP for treating metastatic pancreatic ductal adenocarcinoma (mPDAC) [1][2] Group 1: Clinical Trial Results - The topline data from the Actuate-1801 Part 3B trial show clinically meaningful improvements in primary efficacy measures when elraglusib is combined with GnP compared to GnP alone [2] - Preliminary results indicate statistically significant increases in the 1-year survival rate and median overall survival for patients treated with the elraglusib/GnP combination versus those receiving GnP alone [3] - The combination treatment also led to higher Objective Response Rates (ORR) and Disease Control Rates (DCR) compared to the control arm [3] Group 2: Company Statements and Future Outlook - The CEO of Actuate highlighted the significance of achieving statistical significance in increased survival rates in a Phase 2 trial, emphasizing elraglusib's potential as a promising therapy for mPDAC [4] - The company views elraglusib as a highly valuable late-stage asset with substantial regulatory and commercial potential [4] - Actuate plans to host a KOL event on May 31, 2025, to discuss the data presented at ASCO, featuring discussions with key opinion leaders [6][8] Group 3: Study Design and Methodology - The Actuate-1801 Part 3B study is a randomized, controlled Phase 2 trial involving 286 mPDAC patients, comparing elraglusib with GnP to GnP alone [9] - Elraglusib is administered at a dose of 9.3 mg/kg via IV infusion on Day 1 of each week in a 28-day cycle, with median overall survival as the primary endpoint [9] - Secondary endpoints include DCR, ORR, progression-free survival (PFS), and adverse events (AE) [9] Group 4: Mechanism of Action - Elraglusib, a GSK-3β inhibitor, may enhance chemotherapy efficacy, activate anti-tumor immunity, and regulate gene expression, potentially leading to improved survival outcomes [10][11]