Halozyme announced the HALO-301 Phase 3 clinical study evaluating PEGPH20 as first-line therapy for the treatment of patients with metastatic pancreas cancer failed to reach the primary endpoint of overall survival. Based on these results, Halozyme intends to halt development activities for PEGPH20 and implement an organizational restructuring to focus its operations solely on its ENHANZE® drug delivery technology.
HALO-301 was a randomized, placebo-controlled, double-blind study conducted in patients with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA). The treatment arm of PEGPH20 in combination with gemcitabine and nab-paclitaxel (ABRAXANE®) failed to demonstrate an improvement in median overall survival compared to gemcitabine and nab-paclitaxel alone (11.2 months compared to 11.5 months, HR=1.00, p=0.9692). While there was a higher response rate in the PEGPH20 treatment arm, this did not translate into an improvement in duration of response, Progression-Free Survival or Overall Survival.
Further details regarding the organizational restructuring and other strategic actions to position Halozyme for the future can be found in a separate press release.
PEGPH20 (pegvorhyaluronidase alfa) is the PEGylated version of Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20. rHuPH20 temporarily degrades hyaluronan (HA), which is a naturally occurring glycosaminoglycan or chain of natural sugars that is common throughout the body and can accumulate in the tumor microenvironment of certain solid tumor types.1-3 PEGylating rHuPH20 increases the plasma half-life of the enzyme, which increases exposure following systemic delivery and enables PEGPH20 to target tumor-associated HA in a unique investigational approach to cancer treatment.