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.
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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.
- 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.