Actuate Therapeutics Announces Details for 2025 ASCO Annual Meeting Presentation on Topline Elraglusib Phase 2 Data in First-Line Treatment of Metastatic Pancreatic Cancer

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]