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Poster display session

2061 - Global Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating PEGylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Plus nab-Paclitaxel and Gemcitabine in Patients with Previously Untreated, Hyaluronan (HA)-High, Stage IV Pancreatic Ductal Adenocarcinoma (PDA)

Date

09 Sep 2017

Session

Poster display session

Presenters

Eric Van Cutsem

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

E. Van Cutsem1, A. Hendifar2, M. Reni3, L. Zheng4, M. Ducreaux5, W. Harris6, P. Corrie7, T. Seery8, D. Chondros9, A. Bullock10

Author affiliations

  • 1 Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, 3000 - Leuven/BE
  • 2 Cedars-sinai Medical Center, Samuel Oschin Cancer Center, 90048 - Los Angeles/US
  • 3 Oncology, Ospedale San Raffaele, 20132 - Milano/IT
  • 4 Oncology, The Johns Hopkins University Hospital, 21287 - Baltimore/US
  • 5 Gi Unit, Gustave Roussy, 94805 - Paris/FR
  • 6 Oncology, University of Washington School of Medicine, 98109 - Seattle/US
  • 7 Medical Oncology, Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, CB2 0QQ - Cambridge/GB
  • 8 Infusion Center, University of California - Irvine, 92868 - Irvine/US
  • 9 Clinical, Halozyme Therapeutics, 92121 - San Diego/US
  • 10 Division Of Hematology-oncology, Beth Israel Deaconess Medical Center, 02215 - Boston/US
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Resources

Abstract 2061

Background

Poor outcome in PDA is associated with stromal hyaluronan (HA) accumulation, which may compromise treatment access. In animal models, PEGPH20 degrades tumor HA. Key data from a Phase 2 study showed that PEGPH20 plus chemotherapy improved efficacy over chemotherapy alone in tumors retrospectively identified to accumulate HA (“HA-High”). The objectives of this Phase 3 study are to compare efficacy and safety of standard-dose nab-paclitaxel (NAB) and gemcitabine (GEM) combined with PEGPH20 or placebo in patients with HA-High, previously untreated, Stage IV PDA. Primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints are objective response rate, duration of response, and safety.

Trial design

420 patients ≥18 years with untreated HA-High metastatic PDA, ECOG PS 0-1 are randomized (stratified by North America/Europe/Other) 2:1 to NAB 125 mg/m2 + GEM 1000 mg/m2 + PEGPH20 3.0 μg/kg or to NAB + GEM + placebo, respectively. Patients with HA-High tumors are prospectively identified by the co-developed VENTANA HA RxDx Assay, which identifies HA in the extracellular matrix. HA-High status (indicating patients who may achieve clinical benefit) was determined by Halozyme to be ≥ 50% HA staining based on clinical outcome data from a Phase 2 study. Treatment is provided in 4-week cycles (Wk 1-3, Wk 4 rest) until disease progression, unacceptable toxicity, death, or consent withdrawal. PEGPH20 or placebo is given twice weekly (Cycle 1) then weekly (Cycles 2+), NAB + GEM once weekly for all cycles. Dexamethasone is given before and after PEGPH20 to reduce treatment-related musculoskeletal symptoms and enoxaparin is given to minimize thromboembolic events. Tumor response will be assessed by an independent central imaging vendor using RECIST v1.1. Adverse events will be graded per NCI CTCAE v4.03. An independent Data Monitoring Committee will evaluate safety and efficacy (PFS and OS) data. Trial initiated Q12016 (EudraCT 2015-004068-13; NCT02715804).

Clinical trial identification

NCT02715804

Legal entity responsible for the study

Halozyme Therapeutics, Inc.

Funding

Halozyme Therapeutics, Inc.

Disclosure

E. Van Cutsem: Research funding: Halozyme. A. Hendifar: Consulting or Advisory Role: Genentech, Novartis, Ipsen, Perthera Travel, Accommodations, Expenses: Halozyme. M. Reni: Grant: Celgene, Baxalta, Merck-Serono, Helsinn Personal fee: Celgene, Baxalta, Merck-Serono, Boheringer, Lilly, Pfizer, AstraZeneca, Novocure, Genentech, Halozyme Non-fin support: Celgene. L. Zheng: Consult/Advisory:Merrimack Patents/royal: GVAX,Licensed to Aduro Biotech Stock/Other: Z&L Medical Intl Res Fund: BMyers Squibb,Amgen, Iteos Therap,Gradalis,Merck,Halozyme. M. Ducreaux: Honoraria: Roche,Celgene,Merck Serono,Amgen,Novartis,Sanofi,Pfizer,Lilly,Servier, Halozyme Grants/ResFund: Roche, Chugai, Pfizer Spouse: Head of BU, Sandoz. W. Harris: Consulting or Advisory Role: Neotherma Oncology, Bayer Research Funding: Halozyme, BMS, Exelixis, Argule, Polaris, Medimmune, BTG. P. Corrie: Honor: Roche, Novartis, BM Squibb, Merck Sharpe&Dohme,Pierre Fabre Res fund: Celgene Ad hoc honor for lectures/mtg present: Novartis, Celgene,Merck Sharpe & Dohme. T. Seery: Consulting or Advisory Role: Bayer Speakers\' Bureau: Ipsen, Bayer. D. Chondros: Halozyme employee. A. Bullock: Consulting or advisory board participation support: Halozyme, Celgene, and EMD Serono.

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