Actuate Therapeutics Reports Positive Phase 2 Data for Elraglusib in Pancreatic Cancer, Showing Significant Overall Survival Benefit

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Actuate Therapeutics announced highly encouraging updated Phase 2 data for elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC), a cancer with a high unmet medical need and poor prognosis. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival when elraglusib was combined with standard chemotherapy. The substantial increase in 12-month and especially 24-month survival rates, along with a 38% reduction in the risk of death, suggests a meaningful clinical benefit for patients. The consistent safety profile further strengthens the potential of this therapy. These positive results are a critical de-risking event for the company's lead candidate and could significantly advance its development towards a pivotal Phase 3 trial, potentially transforming treatment options for this devastating disease.

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• Phase 2 Trial Met Primary Endpoint

  The randomized Phase 2 trial (Actuate-1801 Part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met its primary endpoint, demonstrating statistically significant improved overall survival in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

• Significant Overall Survival Benefit

  Median overall survival (OS) was 10.1 months for the elraglusib/GnP arm compared to 7.2 months for GnP alone (p=0.02, HR=0.62), representing a 38% reduction in the risk of death.

• Extended Long-Term Survival Rates

  The 12-month survival rate doubled to 44.4% (elraglusib/GnP) vs. 22.3% (GnP), and the 24-month survival rate increased fivefold to 12.9% in the elraglusib/GnP arm compared to 2.6% in the GnP arm.

• Consistent Safety Profile

  The safety and tolerability profile of elraglusib was consistent with previously reported data, with no new safety signals identified and similar rates of serious adverse events between treatment arms.

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Actuate Therapeutics announced highly encouraging updated Phase 2 data for elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC), a cancer with a high unmet medical need and poor prognosis. The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival when elraglusib was combined with standard chemotherapy. The substantial increase in 12-month and especially 24-month survival rates, along with a 38% reduction in the risk of death, suggests a meaningful clinical benefit for patients. The consistent safety profile further strengthens the potential of this therapy. These positive results are a critical de-risking event for the company's lead candidate and could significantly advance its development towards a pivotal Phase 3 trial, potentially transforming treatment options for this devastating disease.