Halozyme Therapeutics has discontinued the development of PEGylated recombinant human hyaluronidase (PEGPH20) after the investigational drug failed to meet the primary endpoint in a phase 3 trial in metastatic pancreas cancer.
PEGPH20 was being assessed in combination with ABRAXANE (nab-paclitaxel) and gemcitabinein in the HALO-301 study as a first-line therapy for the condition. The late-stage trial enrolled 500 patients with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
According to Halozyme, the treatment arm of the investigational drug combination with gemcitabine and nab-paclitaxel could not deliver an improvement in median overall survival. This was in comparison to gemcitabine and nab-paclitaxel alone.
The company said that although a higher response rate in the PEGPH20 treatment arm was recorded, there was no improvement in duration of response, progression free survival or overall survival.
Halozyme president and CEO 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.”
In October 2014, Halozyme secured orphan drug designation for PEGPH20 from the US Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
The drug is an investigational PEGylated form of Halozyme’s recombinant human hyaluronidase, which was developed for the systemic treatment of tumours that accumulate hyaluronan.
Following the failure in the HALO-301 study, the US biotech company announced plans to undertake an organisational restructuring. The company said that it will now focus its operations only on its ENHANZE drug delivery technology.
Halozyme said that it will also close its oncology operations and will slash nearly 160 jobs. The company expects the restructuring and other cost-saving measures to generate savings of $130-$140m.
Torley said: “Our mission now is to transition our strategy to focus on our high-growth, high-margin ENHANZE drug delivery technology platform.
“Our ENHANZE business is well positioned for this growth, supported by strong partnerships with leading brands and a promising development pipeline. As a result, Halozyme now has a clear path to near-term, sustainable profitability with strong cash flows and high growth prospects.”