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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

5933 - HALO 109-301: Phase 3, randomized, double-blind, placebo-controlled study of pegvorhyaluronidase alfa (PEGPH20) + nab-paclitaxel/gemcitabine (AG) in patients with previously untreated hyaluronan (HA)-high Stage IV pancreatic ductal adenocarcinoma (PDA)

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Clinical Research

Tumour Site

Pancreatic Cancer

Presenters

Eric van Cutsem

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

E. van Cutsem1, P.G. Corrie2, M.P. Ducreux3, D. Sigal4, V. Sahai5, D. Oh6, A. Bullock7, Y. Bang8, A.D. Baron9, A. Hendifar10, C. Li11, P. Philip12, M. Reni13, M. Zalupski14, L. Zheng15, C. Berman16, D. Chondros17, M.A. Tempero18

Author affiliations

  • 1 Department Of Digestive Oncology, University Hospital Gasthuisberg-University of Leuven and KU Leuven, 3000 - Leuven/BE
  • 2 Cancer Division, Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, CB2 0QQ - Cambridge/GB
  • 3 Gi Oncology Unit, Department Of Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 4 Department Of Medical Oncology, Scripps Clinic, 92037 - La Jolla/US
  • 5 Department Of Internal Medicine, Division Of Hematology And Oncology, University of Michigan, Ann Arbor/US
  • 6 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 7 Department Of Hematology-oncology, Beth Israel Deaconess Medical Center, Boston/US
  • 8 Department Of Internal Medicine, Seoul National University Hospital, 3080 - Seoul/KR
  • 9 Division Of Hematology/oncology, California Pacific Medical Center, San Francisco/US
  • 10 Department Of Oncology, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 11 Department Of Medicine, Taipei Veterans General Hospital, Taipei City/TW
  • 12 Barbara Ann Karmanos Cancer Institute, Wayne State University, 48201-2013 - Detroit/US
  • 13 Department Of Oncology, Ospedale San Raffaele, 20132 - Milan/IT
  • 14 Department Of Internal Medicine, University of Michigan, Ann Arbor/US
  • 15 Department Of Oncology, Johns Hopkins University, Baltimore/US
  • 16 Clinical Development, Halozyme Therapeutics, Inc., 92121 - San Diego/US
  • 17 Clinical Development, Halozyme Therapeutics, Inc., San Diego/US
  • 18 San Francisco Pancreas Center, UCSF Helen Diller Family Comprehensive Cancer Center, 94143 - San Francisco/US
More

Resources

Abstract 5933

Background

Poor outcome in PDA is associated with high stromal HA content (HA-high). In vitro, PEGPH20 degrades tumor HA and may increase access and efficacy of tumor therapies. In a Phase 2 study, PEGPH20 + standarddose nabpaclitaxel/gemcitabine (PAG) improved PFS over chemotherapy alone (AG) in tumors retrospectively identified as HA-high. In this Phase 3 study, we investigate the efficacy and safety of PAG vs AG in patients with HA-high, previously untreated, Stage IV PDA. There are 2 primary endpoints: PFS and OS. Secondary endpoints are objective response rate, duration of response, and safety.

Trial design

Patients ≥18 years with untreated HA-high, Stage IV PDA and ECOG PS 0–1 are eligible. Exclusion criteria include a history of thromboembolic events (TEs) or cerebrovascular accident. Patients (N ≤ 570) are randomized 2:1 to PAG (PEGPH20=3.0 μg/kg + A = 125 mg/m2 + G = 1000 mg/m2) or AG (A = 125 mg/m2 + G = 1000 mg/m2) and stratified by region (North America/Europe/Other). HA-high status is prospectively determined by the RxDx Assay and scoring methodology codeveloped by Ventana Medical Systems, Inc., and Halozyme Therapeutics, Inc. The assay identifies HA in the extracellular matrix, with PDA defined as HA-high when the HA score is ≥ 50% based on HA staining. Treatment is provided in 4-week cycles (3 weeks on treatment, 1 week off) until disease progression, unacceptable toxicity, death, or consent withdrawal. PEGPH20 or placebo are dosed twice-weekly (Cycle 1) then weekly (≥Cycle 2); AG is dosed weekly (all cycles). Dexamethasone is used before and after PEGPH20 to reduce PEGPH20-related musculoskeletal symptoms, and enoxaparin prophylaxis is administered subcutaneously once daily at 1 mg/kg to minimize TEs. Tumor response is independently assessed per RECIST v1.1. Adverse events are graded per NCI CTCAE v4.03. An independent data monitoring committee is overseeing the safety data. The trial was initiated in 2016, is open at > 200 study sites across >20 countries, and is expected to complete by 2020.

Clinical trial identification

EudraCT 2015-004068-13; NCT02715804.

Legal entity responsible for the study

Halozyme Therapeutics, Inc.

Funding

Halozyme Therapeutics, Inc.

Editorial Acknowledgement

Medical writing assistance was provided by Tamsin Williamson at Paragon, Knutsford, UK.

Disclosure

E. Van Cutsem: Sponsored clinical trials Investigator: Halozyme P.G. Corrie, M.P. Ducreux, D. Sigal, D.-Y. Oh, A. Bullock, Y.-J. Bang, A.D. Baron, A. Hendifar, C.-P. Li, P. Philip, M. Reni, M. Zalupski, L. Zheng, M.A. Tempero: Sponsored clinical trials Investigator: Halozyme Therapeutics, Inc. V. Sahai: Consultant, Scientific advisory board: Halozyme. C. Berman, D. Chondros: Employee: Halozyme Therapeutics, Inc.

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