Global Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Compare Efficacy and Safety of PEGylated Recombinant Human Hyalu...

Date 29 June 2016
Event ESMO World Congress on Gastrointestinal Cancer 2016
Session ESMO World Congress on Gastrointestinal Cancer 2016 - Abstracts book
Presenter Tempero Margaret
Citation Annals of Oncology (2016) 27 (2): 1-85. 10.1093/annonc/mdw199
Authors T. Margaret1, H. Sunil2, Z. Lei3, R. Michele4, H. Andrew5, D. Michel6, B. Andrea7, C. Pippa8, H. William9, H. Volker10, S. Tara11, W. Wilson12, C. Dimitrios12, V.C. Eric13
  • 1UCSF Pancreas Center, San Francisco, California, USA, /
  • 2Fred Hutchinson Cancer Research Center, Seattle, Washington, USA, /
  • 3The Johns Hopkins University Hospital, Baltimore, Maryland, USA, /
  • 4Ospedale San Raffaele, Milan, Italy, /
  • 5Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California, USA, /
  • 6Gustave Roussy, Villejuif, France, /
  • 7Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA, /
  • 8Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom, /
  • 9University of Washington School of Medicine, Seattle, Washington, USA, /
  • 10Comprehensive Cancer Center, Krebszentrum München, München, Germany, /
  • 11UC Irvine Medical Center, Orange, California, USA, /
  • 12Halozyme Therapeutics, San Diego, California, USA, /
  • 13University Hospital Gasthuisberg, Leuven, Belgium, /

Abstract

Poor outcome in pancreatic cancer (PDA) is associated partly with stromal hyaluronan (HA) accumulation, which compromises chemotherapy access to tumors. PEGPH20 (PEGylated recombinant human hyaluronidase) degrades HA in tumors. In an interim analysis from a Phase 2 study, PEGPH20 in combination with chemotherapy improved efficacy in patient tumors retrospectively identified to accumulate HA (termed “HA-HIGH”). The objectives of this randomized, double-blind, placebo-controlled, global study are to compare efficacy and safety of standard dose nab-paclitaxel (NAB) and gemcitabine (GEM) with either PEGPH20 or placebo in patients with HA-HIGH, previously untreated Stage IV PDA. Primary endpoints include progression-free survival (PFS) and overall survival (OS). Secondary endpoints include objective response rate, duration of response, and safety.