Halozyme Gets PFS, OS Results for PEGPH20

Halozyme Therapeutics posted data from its Phase Ib trial of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) in combination with gemcitabine for the treatment of patients with stage IV metastatic pancreatic cancer. The data indicate mature patient progression free survival (PFS) and ongoing overall survival (OS), suggesting a potential clinical benefit of using PEGPH20 with gemcitabine in patients with high levels of tumor associated hyaluronan (HA).

In this single-arm study, all patients received PEGPH20 in combination with gemcitabine. The primary objective was to determine the recommended Phase II dose. Exploratory analysis evaluated PFS and OS in a subset of patients with available biopsy samples and HA scores. In patients with high levels of tumor HA, PFS was 219 days compared to 108 days for patients with low levels of tumor HA, while OS in the high HA group was 529 days compared to 174 days for the low HA group. OS data is still not mature for the high HA group. With respect to the intent to treat population irrespective of HA status, PFS was 154 days and OS was 200 days.