PEGPH20 May Improve PFS in Pancreatic Cancer

Adding PEGPH20 to nab-paclitaxel and gemcitabine significantly improved progression-free survival among treatment-naive patients with stage IV pancreatic cancer who had high levels of hyaluronan, according to a press release from Halozyme Therapeutics, the developer of PEGPH20.¹

Results from a combined analysis of stages 1 and 2 and stage 2 alone of the multicenter, phase 2 HALO 202 (ClinicalTrials.gov Identifier: NCT01839487) showed that among patients with high levels of hyaluronan, PEGPH20 improved median progression-free survival by 91% compared with nab-paclitaxel and gemcitabine alone. Median progression-free survival was 8.6 months with PEGPH20, nab-paclitaxel, and gemcitabine vs 4.5 months with nab-paclitaxel plus gemcitabine.

The study also showed a reduction in the rate of thromboembolic events in the PEGPH20 treatment arm, the study’s secondary end point.

The international, double-blind, phase 3 HALO 301 trial (ClinicalTrials.gov Identifier: NCT02715804) is evaluating PEGPH20 in combination with nab-paclitaxel and gemcitabine compared with placebo plus nab-paclitaxel and gemcitabine as first-line therapy in patients with stage IV, hyaluronan-high, previously untreated pancreatic ductal adenocarcinoma. The primary end points are progression-free survival and overall survival.

PEGPH20 is an investigational pegylated form of recombinant human hyaluronidase that temporarily degrades hyaluronan, a dense component of the tumor microenvironment that can potentially cause vasoconstriction, limiting the access of other therapies.

The U.S. Food and Drug Administration granted orphan drug designation to PEGPH20 for the treatment of pancreatic cancer and Fast Track status for PEGPH20 in combination with gemcitabine and protein-bound paclitaxel for metastatic pancreatic cancer.

Reference

1. Halozyme announces phase 2 study in advanced pancreas cancer meets key endpoints. Halozyme website. http://www.halozyme.com/investors/news-releases/news-release-details/2017/Halozyme-Announces-Phase-2-Study-In-Advanced-Pancreas-Cancer-Meets-Key-Endpoints/default.aspx. Published January 5, 2017. Accessed January 6, 2017.