HALO-301 Phase III study of PEGPH 20 + Abraxane + gemcitabine fails to meet endpoint in pancreatic cancer.- Halozyme Therapeutics

Halozyme Therapeutics announced that the HALO-301 Phase III clinical study evaluating investigational new drug PEGPH20 as a first-line therapy for treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival. The treatment arm of PEGPH20 in combination with gemcitabine and nab-paclitaxel (Abraxane) failed to demonstrate an improvement in median overall survival compared to gemcitabine and nab-paclitaxel alone (11.2 months compared to 11.5 months, HR=1.00, p=0.9692). While there was a higher response rate in the PEGPH20 treatment arm, this did not translate into an improvement in duration of response, Progression Free Survival or Overall Survival. Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of Abraxane plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013.

Based on the lack of benefit over standard-of-care in this study, which performed well versus published data, the company will be discontinuing PEGPH20 clinical development Halozyme intends to halt development activities for PEGPH20 and implement an organizational restructuring to focus its operations solely on its ENHANZE drug delivery technology.