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Niraparib therapy in patients with newly diagnosed advanced ovarian cancer after chemotherapy: PRIMA/ENGOT-OV26/GOG-3012 study
  1. A González-Martín1,
  2. B Pothuri2,
  3. I Vergote3,
  4. RD Christensen4,
  5. W Graybill5,
  6. MR Mirza6,
  7. C McCormick7,
  8. D Lorusso8,
  9. P Hoskins9,
  10. G Freyer10,
  11. K Baumann11,
  12. K Jardon12,
  13. A Redondo13,
  14. RG Moore14,
  15. C Vulsteke15,
  16. RE O’Cearbhaill16,
  17. B Lund17,
  18. F Backes18,
  19. P Barretina-Ginesta19,
  20. AF Haggerty20,
  21. MJ Rubio-Pérez21,
  22. MS Shahin22,
  23. G Mangili23,
  24. WH Bradley24,
  25. I Bruchim25,
  26. K Sun26,
  27. I Malinowska26,
  28. Y Li26,
  29. D Gupta26 and
  30. BJ Monk27
  1. 1Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Medical Oncology Department, Clínica Universidad de Navarra, Madrid, Spain
  2. 2Gynecologic Oncology Group (GOG) and Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA
  3. 3Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and Department of Gynaecology and Obstetrics, Division of Gynaecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium
  4. 4Nordic Society of Gynaecological Oncology (NSGO) and Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark
  5. 5GOG and Gynecologic Oncology, Medical University of South Carolina, Charleston, SC, USA
  6. 6NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen, Denmark
  7. 7GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR, USA
  8. 8Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Fondazione IRCCS National Cancer Institute of Milan, Milan, Italy
  9. 9US Oncology Research (USOR) and Department of Medical Oncology, BC Cancer – Vancouver, Vancouver, BC, Canada
  10. 10Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO) and Service d’Oncologie Médicale, Centre Hospitalier Lyon-Sud, Lyon, France
  11. 11Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany
  12. 12GOG and Department of Obstetrics and Gynecology, McGill University, Department of Oncology, McGill University Health Centre, Division of Gynecologic Oncology, Montreal, QC, Canada
  13. 13GEICO and Hospital Universitario La Paz-IdiPAZ, Madrid, Spain
  14. 14USOR and Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester, NY, USA
  15. 15BGOG and Department of Medical Oncology and Hematology, AZ Maria Middelares, Gent, and Department of Molecular Imaging, Pathology, Radiotherapy and Oncology, Center for Oncological Research, Antwerp University, Antwerp, Belgium
  16. 16GOG and Department of Medicine, Memorial Sloan Kettering Cancer Center, Department of Medicine, Weill Cornell Medical College, New York, NY, USA
  17. 17NSGO and Department of Oncology, Aalborg University, Aalborg, Denmark
  18. 18Division of Gynecologic Oncology, Ohio State University, Columbus, OH, USA
  19. 19GEICO and Medical Oncology Department, Catalan Institute of Oncology (ICO) – Hospital Universitari Dr Josep Trueta, and Department of Medical Sciences, Medical School University of Girona, Girona, Spain
  20. 20GOG and Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia, PA, USA
  21. 21GEICO and Hospital Universitario Reina Sofía, Cordoba, Spain
  22. 22GOG and Hanjani Institute for Gynecologic Oncology, Asplundh Cancer Pavilion, Abington Jefferson Hospital, Sidney Kimmel Medical College of Thomas Jefferson University, Willow Grove, PA, USA
  23. 23MITO and Department of Obstetrics and Gynaecology, San Raffaele Scientific Institute, Milan, Italy
  24. 24GOG and Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee, WI, USA
  25. 25Israeli Society of Gynecologic Oncology (ISGO) and Department of Gynecology and Gynecologic Oncology, Hillel Yaffe Medical Center, Technion Israel Institute of Technology, Haifa, Israel
  26. 26TESARO: A GSK Company, Waltham, MA
  27. 27Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA


Introduction/Background Niraparib improves progression-free survival (PFS) in patients (pts) with newly diagnosed advanced ovarian cancer after 1st-line (1L) platinum-based chemotherapy (CT). We report the efficacy of niraparib in pts by biomarker status.

Methodology This double-blind, placebo (PBO)-controlled, phase 3 study randomized 733 pts with newly diagnosed advanced 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 (CR/PR), receipt of neoadjuvant CT (yes/no), and homologous recombination status (deficient/proficient/not determined). Pts received niraparib or PBO once daily. The primary endpoint of PFS assessed by blinded independent central review was analyzed using a stratified Cox proportional hazards model and hierarchically tested in homologous recombination deficient pts, then the overall population.

Results Of 733 randomized pts (niraparib, 487; PBO, 246), 373 (51%) were homologous recombination deficient (niraparib, 247; PBO, 126) and 249 (34%) were homologous recombination proficient (niraparib, 169; PBO, 80). Overall, 35% had stage IV disease, 67% received NACT, and 31% had a PR to 1L CT. Niraparib-treated pts in all the biomarkers groups had a statistically significant and clinically meaningful benefit in PFS (table 1). The most common grade ≥3 adverse events were anemia (31%), thrombocytopenia (29%), and neutropenia (13%).

Abstract – Table 1

Conclusion Niraparib improved PFS as evidenced by reduction in the risk of recurrence or death due to any cause in the overall population of advanced ovarian cancer. No new safety signals were identified.

CI=confidence interval; mut=mutated; wt=wild type

Disclosure AMG: Consulting: AstraZeneca, TESARO, Roche, Pharmamar, Clovis, Merck, Genmab, ImmunoGen, Oncoinvent AS BP, RDC: Advisory: TESARO IV: Personal: Advaxis, Eisai, MSD Belgium, Roche NV, Genmab, Roche, Pharmamar, Millennium Pharmaceuticals, Clovis, Astrazeneca NV, Tesaro, Immunogen, Sotio. Grants: Amgen, Stichting tegen Kanker, Roche. Contracted Research: Oncoinvent AS, Genmab WG: Consulting: TESARO MM: Leadership/Other ownership: Karyopharm Therapeutics, Sera Prognostics. Personal Fees: Roche, AstraZeneca, Clovis, Pfizer, TESARO, Genmab, BioCad, Sotio, Geneos Therapeutics, Merck, Oncology Venture, Seattle Genetics, Sera Prognostics, Takeda, Zailab. Grants: AstraZeneca, Clovis, Pfizer, TESARO, Boehringer Ingelheim CCM, PH, KHB, KJ, CGAV, BL, AFH, MJR-P, WHB, IB: none DL: Personal: AstraZeneca, Clovis, Genmab, Immunogen, Pharma Mar SA, Amgen, Merck. Grants: Pharma Mar SA, Merck GF: Personal: TESARO, AstraZeneca, Clovis, Roche, Bristol-Meyers Squibb, MSD, Pfizer, Novartis. Grants: AstraZeneca, Roche AR: Research funding/Advisory role: Pharmamar, Roche, Eisai,AstraZeneca, TESARO RGM: Research: Angle PLC. Consulting: Fujirebio Diagnostics REO: Advisory: Clovis, TESARO, GlaxoSmithKline FB: Advisory: TESARO, Clovis, Agenus, Merck, Eisai. Grant: Clovis, Merck, Eisai, Immunogen. Lecture: CEC Oncology MPBG: Lecture/Advisory board: TESARO, AstraZeneca, Roche, Clovis, Pharmamar, MSD. MSS: Personal: TESARO, Merck, Astra Zeneca, Clovis, Pacira Pharamceuticals. Grant: TESARO GM: Personal: AstraZeneca, TESARO. Non-Financial Support: TESARO, Roche. BJM: Speaker bureau, Grant: TESARO KS, IM, YL, DG: TESARO employee.

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