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Halozyme Presents PEGPH20 Phase 1b Clinical Trial Data at European Cancer Congress 2013
Date:9/30/2013

A from tumors and improve perfusion and drug delivery to the tumor bed. The data from this trial suggest that similar processes may be occurring in patients as well and that patients with high levels of HA may derive the most treatment benefit from PEGPH20 combination therapy," stated Sunil R. Hingorani, M.D., Ph.D., Associate Member of the Clinical Research and Public Health Divisions at Fred Hutchinson Cancer Research Center and lead investigator for this study. "Pancreatic cancer is a devastating disease, and these data provide intriguing evidence for a new treatment paradigm. We look forward to the results for PEGPH20 in large randomized Phase 2 trials with the most active chemotherapy regimens available to definitively establish the potential benefit of this strategy and correlation with HA status."

Additional Study Details

This study enrolled 28 patients with stage IV treatment naïve pancreatic ductal adenocarcinoma. Patients were treated with one of three doses of PEGPH20 (1.0, 1.6 and 3.0 µg/kg twice weekly for four weeks, then weekly thereafter) in combination with gemcitabine 1000 mg/m2 administered intravenously. The overall response rate (ORR) (complete response + partial response) by RECIST 1.1 criteria was 42 percent (10 of 24 patients, 95 percent CI 22 – 62 percent) in the intent to treat population for those treated at therapeutic dose levels of PEGPH20 (1.6 and 3.0 µg/kg). Additionally, 43 percent of evaluable patients saw a reduction of at least 70 percent in serum carbohydrate antigen 19-9 (CA 19-9), a biomarker of tumor cell burden.1 In the intent to treat population, 17 patients had biopsies evaluable for HA scoring. The method of HA scoring was prospectively defined for tumor-cell associated and stromal associated tissue, and assessed by central pathology laboratory evaluation. The ORR in patients with tumor-cell associated high HA was 83 percent, indicating
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