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Poster display session

2062 - A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 3 Trial of Niraparib Maintenance Treatment in Patients with Advanced Ovarian Cancer Following Frontline Chemotherapy


09 Sep 2017


Poster display session


Cytotoxic Therapy;  Ovarian Cancer


Antonio Gonzalez Martin


Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372


A. Gonzalez Martin1, L.A. Rojas2, P.S. Braly3, J. Barter4, D.M. O'Malley5, A.M. Oza6, A.F. Haggerty7, C. Vulsteke8, D.M. Provencher9, W. Graybill10, Y. Li11, I.A. Malinowska12, M.R. Mirza13, I. Vergote14, B. Pothuri15, B.J. Monk16

Author affiliations

  • 1 Servicio De Oncologia Medica, Grupo Español de Investigación en Cáncer de Ovario (GEICO) & MD Anderson Cancer Center Center Espana, 28033 - Madrid/ES
  • 2 Gynecologic Oncology, Avera Cancer Institute, Sioux Falls/US
  • 3 Gynecologic Oncology, Women's Cancer Care, Covington/US
  • 4 Gynecologic Oncology, Holy Cross Hospital, Silver Spring/US
  • 5 Gynecologic Oncology, The Ohio State University Medical Center, Columbus/US
  • 6 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 7 Gynecologic Oncology, The University of Pennsylvania, Philadelphia/US
  • 8 Molecular Imaging, Pathology, Radiotherapy & Oncology, Center For Oncological Research, Antwerp University, Antwerp/BE
  • 9 Obstetrics And Gynecology, Centre Hospitalier de L'Universite de Montreal (CHUM), Montreal/CA
  • 10 Gynecologic Oncology, Medical University of South Carolina, Charleston/US
  • 11 Biostatistics, Tesaro, Inc., Waltham/US
  • 12 Clinical Science, Tesaro, Inc., Waltham/US
  • 13 Oncology, Nordic Society of Gynecologic Oncology (NSGO) and Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 14 Obstetrics And Gynaecology, Belgian Gynecologic Oncology Group (BGOG) and University of Leuven, Leuven Cancer Institute, Leuven/BE
  • 15 Obstetrics & Gynecology, NYU Langone Medical Center, New York/US
  • 16 Obstetrics And Gynecology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph's Hospital, Phoenix/US


Abstract 2062


Niraparib (ZEJULA™) is a selective poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor. In preclinical studies, niraparib concentrated in the tumor vs plasma, delivering ≥90% durable PARP 1/2 inhibition and a persistent antitumor effect. In the ENGOT-OV16/NOVA trial, niraparib demonstrated clinical efficacy in patients with recurrent ovarian cancer (OC) following complete response (CR) or partial response (PR) to platinum-based chemotherapy (PBC) regardless of BRCA mutation or homologous recombination deficiency (HRD) status.

Trial design

The primary objective of the ongoing ENGOT-OV26/PRIMA trial is efficacy (measured as progression-free survival) of niraparib vs placebo in advanced OC patients with CR or PR following frontline PBC. Secondary objectives include overall survival, patient-reported outcomes (PROs), time to first subsequent therapy, time to progression on the next anticancer therapy, and safety and tolerability of niraparib. Target enrollment is ≈330 patients with stage III or IV OC with PR or CR after PBC. Eligibility criteria include all patients with stage IV disease and patients with stage III disease who were treated with neoadjuvant chemotherapy followed by interval debulking surgery or who have either inoperable disease or visible residual disease after primary debulking surgery. Patients are stratified based on HRD status (HRD positive, including the known deleterious BRCA mutations gBRCAmut or sBRCAmut/HRD negative), neoadjuvant chemotherapy (yes/no), and best response to PBC (CR/PR). Patients are randomized 2:1 to oral niraparib 300 mg or matched placebo once daily in 28-day cycles. PRO data will be collected.

Clinical trial identification


Legal entity responsible for the study

Tesaro, Inc.


Tesaro, Inc.


A. Gonzalez Martin: Consulting or Advisory Role: Roche, PharmaMar, AstraZeneca; Speakers\' Bureau: Roche, PharmaMar, AstraZeneca; Travel, Accommodations, Expenses: Roche, PharmaMar, AstraZeneca. L.A. Rojas: Research funding: Pfizer. P.S. Braly: Speaker\'s Bureau: Clovis Oncology, Roche, Myriad Genetics; Research Funding: AstraZeneca, Tesaro, Janssen, PharmaMar. J. Barter: Speakers\' Bureau: Baxter. D.M. O\'Malley: Consulting or Advisory: Janssen Oncology, Eisai, AstraZeneca, Clovis Oncology, Genentech/Roche, Amgen, Tesaro, Novocure. A.M. Oza: Consulting or Advisory Role: Amgen, Verastem, Clovis Oncology, Immunovaccine; Travel, Accomodations, Expenses: AstraZeneca Honoraria: WebRx. C. Vulsteke: Consulting or Advisory Role: Novartis, LEO Pharma, Roche; Travel, Accommodations, Expenses: Novartis, Pfizer, Roche. D.M. Provencher: Consulting or Advisory Role: AstraZeneca; Speakers\' Bureau: AstraZeneca. W. Graybill: Consulting or Advisory Role: Tesaro. Y. Li: Employment: Tesaro; Stock and other ownership interests: Tesaro. I.A. Malinowska: Employment: Tesaro; Stock and Other Ownership Interests: Tesaro. M.R. Mirza: Consulting or Advisory Role: Clovis Oncology, AstraZeneca, Tesaro. I. Vergote: Travel, Accomodations, Expenses: GCI Health, Roche, Oasmia Pharmaceutical AB, PharmaMar, AstraZeneca. B. Pothuri: Research funding: Tesaro, Caris Life Sciences, Celgene, Clovis Oncology. B.J. Monk: Consulting/Advisory: GSK, Merck, Tesaro, Roche/GNE, AZ, Gradalis, Advaxis, Verastem, Cerulean, Amgen, Vermillion, Immunogen, Bayer, NuCana BioMed, Insys Therapeutics, Clovis Onc, Oxigene, Pfizer; Speakers Bureau: Roche/GNE, AZ, Janssen, Myriad Genetics. All other authors have declared no conflicts of interest.

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