Halozyme Announces Phase 2 Study in Advanced Pancreas Cancer Meets Key Endpoints

Halozyme Therapeutics has reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.

"These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer," said Dr. Helen Torley, president and CEO. "We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide."

Dr. Sunil R. Hingorani, the principal investigator leading this trial, and a pancreas cancer expert at Fred Hutchinson Cancer Research Center and professor at University of Washington School of Medicine, said: "The Study 202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment. The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study."

Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease.