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Niraparib therapy in patients with newly diagnosed advanced ovarian cancer (PRIMA/ENGOT-OV26/GOG-3012 study)

Date

28 Sep 2019

Session

Presidential Symposium I

Presenters

Antonio González Martín

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

A. González Martín1, B. Pothuri2, I.B. Vergote3, R.D. Christensen4, W. Graybill5, M.R. Mirza6, C. McCormick7, D. Lorusso8, P. Hoskins9, G. Freyer10, F. Backes11, K. Baumann12, A. Redondo13, R.G. Moore14, C. Vulsteke15, R.E. O'Cearbhaill16, B. Lund17, Y. Li18, D. Gupta18, B.J. Monk19

Author affiliations

  • 1 Medical Oncology, Grupo Español de Investigación en Cáncer de Ovario (GEICO) & Clinica Universidad de Navarra, 28036 - Madrid/ES
  • 2 Obstetrics And Gynecology, Gynecologic Oncology Group (GOG), Perlmutter Cancer Center, NYU Langone Cancer Center, New York/US
  • 3 Gynaecology And Obstetrics, Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Division of Gynaecologic Oncology, University Hospitals Leuven, Leuven Cancer Institute, 3000 - Leuven/BE
  • 4 Oncology, Nordic Society of Gynaecological Oncology (NSGO), Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense/DK
  • 5 Gynecologic Oncology, GOG, Medical University of South Carolina, Charleston/US
  • 6 Oncology, Nordic Society of Gynecologic Oncology (NGSO) and Rigshospitalet, Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 7 Oncology, GOG, Legacy Medical Group Gynecologic Oncology, Portland/US
  • 8 Oncology, Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Fondazione IRCCS National Cancer Institute of Milan, Milan/IT
  • 9 Medical Oncology, US Oncology Research (USOR) BC Cancer – Vancouver, Vancouver/CA
  • 10 Medical Oncology, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Lyon/FR
  • 11 Gynecologic Oncology, Ohio State University, Columbus/US
  • 12 Gynecology And Obstetrics, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO), Klinikum der Stadt Ludwigshafen, Ludwigshafen/DE
  • 13 Oncology, GEICO, Hospital Universitario La Paz-IdiPAZ, Madrid/ES
  • 14 Obstetrics And Gynecology, USOR, Wilmot Cancer Institute, University of Rochester, Rochester/US
  • 15 Medical Oncology And Hematology, BGOG, AZ Maria Middelares and Center for Oncological Research, Antwerp University, Antwerp/BE
  • 16 Gynecologic Medical Oncology, GOG, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York City/US
  • 17 Oncology, NSGO, Aalborg University Hospital, Aalborg/DK
  • 18 Clinical Science, TESARO: A GSK Company, Waltham/US
  • 19 Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix/US
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Background

Niraparib has shown progression-free survival (PFS) benefit in recurrent OC after platinum-based chemotherapy (CT) in all patients (pts) regardless of BRCA status. This study evaluated the efficacy of niraparib in pts with newly diagnosed advanced OC after completion of first-line (1L) CT regardless of BRCA status.

Methods

This double-blind, placebo (PBO)-controlled phase III trial evaluated niraparib in pts with newly diagnosed advanced high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response (CR or PR) to 1L platinum-based CT. Stratification factors were best response to the 1L CT regimen (CR/PR), receipt of neoadjuvant CT (NACT; yes/no), and homologous recombination deficiency (HRD) status (positive/negative/unknown) per the Myriad myChoice HRD test. Pts received niraparib or PBO once daily. PFS assessed by blinded independent central review was the primary end point, analyzed using a stratified Cox proportional hazards model and hierarchically tested in HRD-positive (HRDpos) pts and then the overall population.

Results

Of 733 randomized pts (niraparib, 487; PBO, 246), 373 (51%) were HRDpos (niraparib, 247; PBO, 126). Overall, 35% had stage IV disease, 67% received NACT, and 31% had a PR to 1L CT. Niraparib-treated pts in the HRDpos subgroup and overall population had a significant reduction in the risk of disease recurrence or death with a substantial improvement in PFS (Table). All subgroups showed a sustained and durable treatment effect. The most common grade ≥3 adverse events were anemia (31%), thrombocytopenia (29%), and neutropenia (13%). No treatment-related deaths occurred.Table:

LBA1

Niraparib mPFS (95% CI)PBO mPFS (95% CI)Hazard Ratio (95% CI) P Value
HRDpos subgroup21.9 (19.3–NE)10.4 (8.1–12.1)0.43 (0.31–0.59) P < 0.0001
Overall population13.8 (11.5–14.9)8.2 (7.3–8.5)0.62 (0.5–0.75) P < 0.0001

CI, confidence interval; mPFS, median progression-free survival; NE, not estimable.

Conclusions

Niraparib significantly improved PFS in pts with newly diagnosed advanced OC, including pts at high risk of progressive disease in the HRDpos subgroup and overall population. No new safety signals were identified. Niraparib should be considered as a treatment option for pts with advanced OC after completion of 1L CT.

Clinical trial identification

NCT02655016.

Editorial acknowledgement

Writing and editorial support, funded by Tesaro, a GSK Company (Waltham, MA, USA) and coordinated by Ashujit Tadge, PhD of TESARO, was provided by Nicole Renner, PhD of Ashfield Healthcare Communications (Middletown, CT, USA) and Adrienne M. Schreiber, of Tesaro (Waltham, MA, USA).

Legal entity responsible for the study

Tesaro: A GSK Company.

Funding

Tesaro: A GSK Company.

Disclosure

A. González Martín: Research grant / Funding (institution): Roche; Advisory / Consultancy: AstraZeneca Tesaro; Advisory / Consultancy: Pharmamar; Advisory / Consultancy: Tesaro, Inc.. B. Pothuri: Advisory / Consultancy: Tesaro, Inc.; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Intuitive. I.B. Vergote: Advisory / Consultancy: GCI Health, Oncoinvent AS, Roche NV; Research grant / Funding (institution): Roche; Advisory / Consultancy: Genmab A/S, Advaxid Inc, Morphotek Inc; Advisory / Consultancy: F. Hoffmann-La Roche Ltd, Cerulean Pharma Inc, Novocure GMBH; Advisory / Consultancy: AstraZeneca, Mateon Therapeutics Inc; Advisory / Consultancy: Immunogen, Eli Lilly; Advisory / Consultancy, Research grant / Funding (self): Amgen; Advisory / Consultancy: Theradex Europe Limited, Pfizer, Debiopharma International SA; Advisory / Consultancy: Vifor Pharma Belgie NV, Novartis, MSD Belgium BVBA; Advisory / Consultancy: Oxigene, Janssen-Dilag, Nektar Therapeutics, Bayer; Travel / Accommodation / Expenses: Tesaro, Theradex, Elsevier. R.D. Christensen: Advisory / Consultancy: Tesaro: A GSK Company. W. Graybill: Advisory / Consultancy, Speaker Bureau / Expert testimony: Tesaro, Inc.. M.R. Mirza: Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro, Inc.. D. Lorusso: Honoraria (self), Personal fees: AstraZeneca; Honoraria (self), Personal fees: Clovis Oncology; Honoraria (self), Personal fees: Genmab; Honoraria (self), Personal fees: Immunogen; Honoraria (self), Personal fees: Pharma Mar S.A; Honoraria (self), Personal fees: Amgen; Honoraria (self), Personal fees: Merck; Research grant / Funding (institution): Pharma Mar S.A; Research grant / Funding (institution): Merck. G. Freyer: Honoraria (self), Personal fees: Tesaro: A GSK Company; Honoraria (self), Personal fees: Clovis Oncology; Honoraria (self), Personal fees: Bristol-Myers Squibb ; Honoraria (self), Personal fees: MSD; Honoraria (self), Personal fees: Pfizer Inc. ; Honoraria (self), Personal fees: Novartis; Honoraria (self), Personal fees: Eli Lilly ; Honoraria (self), Personal fees: Biogara S.A.S; Honoraria (self), Research grant / Funding (institution), Personal fees: AstraZeneca; Honoraria (self), Research grant / Funding (institution), Personal fees: Roche Holding AG ; Honoraria (self), Research grant / Funding (institution), Personal fees: Mylan. F. Backes: Honoraria (self), Advisory / Consultancy, Personal fees: Clovis Oncology ; Honoraria (self), Advisory / Consultancy, Personal fees: Merck ; Honoraria (self), Advisory / Consultancy, Personal fees: Eisai ; Honoraria (self), Personal fees: Tesaro; Honoraria (self), Personal fees: Agenus; Honoraria (self), Personal fees: CEC Oncology; Research grant / Funding (institution): Immunogen. A. Redondo: Advisory / Consultancy, Research grant / Funding (institution): Pharmamar; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Research grant / Funding (institution): Eisai. R.G. Moore: Research grant / Funding (institution): Angle PLC; Advisory / Consultancy: Fugirebio Diagnostics Inc. R.E. O’Cearbhaill: Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: GlaxoSmithKline. Y. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Tesaro, Inc.. D. Gupta: Shareholder / Stockholder / Stock options, Full / Part-time employment: Tesaro, Inc.. B.J. Monk: Honoraria (self), Advisory / Consultancy: AbbVie, Advaxis; Honoraria (self), Advisory / Consultancy: Agenus, Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca, Biodesix; Honoraria (self), Advisory / Consultancy: Clovis, Conjupro; Honoraria (self), Advisory / Consultancy: Genmab, Gradalis; Honoraria (self), Advisory / Consultancy: ImmunoGen, Immunomedics; Honoraria (self), Advisory / Consultancy: Incyte, Janssen; Honoraria (self), Advisory / Consultancy: Mateon, Merck; Honoraria (self), Advisory / Consultancy: Myriad, Perthera; Honoraria (self), Advisory / Consultancy: Pfizer, Precision; Honoraria (self), Advisory / Consultancy: Puma, Roche; Honoraria (self), Advisory / Consultancy: Samumed, Takeda; Honoraria (self), Advisory / Consultancy: Tesaro, VB. All other authors have declared no conflicts of interest.

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