Halozyme stops PEGPH20 development after Phase III trial fails

5th November 2019 (Last Updated December 24th, 2019 06:58)

Halozyme Therapeutics has announced plans to discontinue the development of its investigational cancer drug, PEGPH20, after it failed in the Phase III HALO-301 clinical trial involving metastatic pancreatic cancer patients.

Halozyme Therapeutics has announced plans to discontinue the development of its investigational cancer drug, PEGPH20, after it failed in the Phase III HALO-301 clinical trial involving metastatic pancreatic cancer patients.

The trial assessed the combination of PEGPH20 with gemcitabine and nab-paclitaxel (Abraxane).

It did not meet the primary endpoint, where the combination failed to show an improvement in median overall survival versus gemcitabine and nab-paclitaxel alone.

The company added that PEGPH20 demonstrated a higher response rate. However, no improvements were observed in overall survival, duration of response or progression-free survival.

Halozyme Therapeutics president and CEO Dr Helen Torley said: “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, we will be discontinuing PEGPH20 clinical development. This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected.”

The company plans to restructure to focus on its Enhanze drug delivery technology, including discontinuation of PEGPH20 development activities and closing its oncology operations.

As part of the restructuring, the company will cut nearly 55% or 160 jobs. Halozyme said that 80% of the reduction will be completed by January next year.

The remaining 120 employees will work to bolster Enhanze technology, primarily in areas required to support partners such as product development, manufacturing, quality and regulatory.

In addition, 12 employees will promote Halozyme’s commercial drug Hylenex.

Restructuring and additional cost-saving efforts are expected to save $130m to $140m for the company next year.