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13 Efficacy on individualized starting dose (ISD) and fixed starting dose (FSD) of niraparib per investigator-assessment (IA) in newly diagnosed advanced ovarian cancer (OC)
  1. W Graybill1,
  2. M Mirza2,
  3. A González-Martin3,
  4. D O’Malley4,
  5. L Gaba5,
  6. OWS Yap6,
  7. E Guerra7,
  8. PG Rose8,
  9. J Baurain9,
  10. S Ghamande10,
  11. H Denys11,
  12. E Prendergast12,
  13. C Pisano13,
  14. P Follana14,
  15. EI Braicu15,
  16. PM Calvert16,
  17. J Korach17,
  18. Y Li18,
  19. D Gupta18 and
  20. BJ Monk19
  1. 1Gynecologic Oncology Group (GOG) and Department of Gynecologic Oncology, Medical University of South Carolina, USA
  2. 2Nordic Society of Gynaecological Oncology (NSGO) and Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Denmark
  3. 3Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Medical Oncology Department, Clínica Universidad de Navarra, Spain
  4. 4The Ohio State University – James CCC, USA
  5. 5Hospital Clinic de Barcelona, Medical Oncology Department, Spain
  6. 6University Gynecologic Oncology, USA
  7. 7Hospital Universitario Ramón y Cajal, Spain
  8. 8Cleveland Clinic, USA
  9. 9Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Belgium
  10. 10Georgia Cancer Center, Augusta University, USA
  11. 11Ghent University Hospital, Belgium
  12. 12Minnesota Oncology, USA
  13. 13Istituto Nazionale Tumori IRCCS Fondazione Pascale, Italy
  14. 14GINECO and Centre Antoine Lacassagne, France
  15. 15Charité Medical University, Germany
  16. 16Cancer Trials Ireland, Ireland
  17. 17Department of Gynecologic Oncology, Chaim Sheba Medical Center, Israel
  18. 18GlaxoSmithKline, USA
  19. 19Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, USA


Introduction Niraparib is a poly(ADP-ribose) polymerase inhibitor approved for maintenance treatment of patients with newly diagnosed or recurrent OC that responded to platinum-based chemotherapy and treatment in heavily-pretreated recurrent OC. Here we report efficacy in patients receiving the FSD and ISD in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016).

Methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients to receive niraparib or placebo for 36 months or until disease progression/toxicity. A protocol amendment introduced ISD: 200 mg in patients with body weight <77 kg or platelets <150,000/µL, or 300 mg in all others. The primary endpoint was PFS by blinded independent central review (BICR). IA PFS was a sensitivity analysis. At the primary analysis data cut, follow-up was 11.2 months and 17.1 months in the ISD and FSD subgroups, respectively. An ad hoc analysis of IA PFS was performed using an updated data cut with additional 6 months follow-up.

Results BICR and IA PFS were highly concordant in the overall population. Efficacy of niraparib based on IA PFS in FSD vs ISD subgroups for each data cut were similar (table 1). Dose interruptions, modifications, and hematologic toxicity were lower with the ISD. Exposure–response data supported the clinical data.

Abstract 13 Table 1

Conclusions The 200- or 300-mg ISD by baseline body weight and platelet counts demonstrated comparable efficacy while improving the safety profile of niraparib. Use of this regimen for first-line maintenance of advanced OC patients is approved by the US FDA.

Funded by: GlaxoSmithKline

NCT: NCT02655016

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