Actuate Therapeutics announced positive topline results from its Phase 2 trial of elraglusib combined with gemcitabine/nab-paclitaxel (GnP) for first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). The combination therapy showed a statistically significant improvement in overall survival compared to GnP alone, surpassing previous data analysis. The trial met its primary endpoint for overall survival and confirmed a significant one-year survival rate, while also demonstrating a favorable risk-benefit profile.
This news offers a potential breakthrough for mPDAC patients, a cancer with historically limited treatment advances and poor survival rates. The substantial improvement in overall survival seen with the elraglusib/GnP combination suggests a new and potentially more effective treatment approach for this aggressive disease. This could significantly impact patient outcomes and potentially reshape the standard of care for mPDAC.
The Phase 2 trial involved 286 patients randomized 2:1 to receive either elraglusib plus GnP or GnP alone. Elraglusib, a novel GSK-3β inhibitor, works by targeting pathways involved in tumor growth and resistance to chemotherapy. The improved survival data, specifically the median overall survival and one-year survival rate, will be presented at the upcoming ASCO Annual Meeting.
Actuate plans to work with regulatory agencies to expedite elraglusib’s commercialization. If approved, this therapy could represent a major advancement in the treatment of mPDAC, offering new hope for patients facing this challenging diagnosis. The positive results from this trial set the stage for further development and potential regulatory filings, suggesting a promising future for elraglusib in the fight against pancreatic cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
