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#161 Final overall survival and long-term safety in the ENGOT-OV16/NOVA phase 3 trial of niraparib in patients with recurrent ovarian cancer
  1. Mansoor R Mirza1,
  2. Jørn Herrstedt2,
  3. Amit Oza3,
  4. Sven Mahner4,
  5. Andrés Redondo5,
  6. Dominique Berton6,
  7. Jonathan S Berek7,
  8. Charlotte A Haslund8,
  9. Frederik Marmé9,
  10. Antonio González-Martín10,
  11. Stéphanie Becourt11,
  12. Anna V Tinker12,
  13. Jonathan Ledermann13,
  14. Benedict Benigno14,
  15. Gabriel Lindahl15,
  16. Nicoletta Colombo16,
  17. Izabela A Malinowska17,
  18. Wenlei Liu17,
  19. Bradley J Monk18 and
  20. Ursula Matulonis19
  1. 1Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, and Nordic Society of Gynaecological Oncology-Clinical Trial Unit, Copenhagen, Denmark
  2. 2Department of Clinical Oncology and Palliative Care, Zealand University Hospital Roskilde and Næstved University of Copenhagen, Copenhagen, Denmark
  3. 3Division of Medical Oncology and Hematology, Cancer Clinical Research Unit at Princess Margaret Cancer Centre, Ontario, Toronto, Canada
  4. 4Department of Obstetrics and Gynecology, University Hospital LMU, Munich, Germany
  5. 5Hospital Universitario La Paz – IdiPAZ, Madrid, Spain
  6. 6GINECO and Institut de Cancerologie de l’Ouest, Centre René Gauducheau, Saint-Herblain, France
  7. 7Stanford Women’s Cancer Center, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, USA
  8. 8Department of Oncology, Aalborg University Hospital, Aalborg, Denmark
  9. 9Medical Faculty Mannheim, Heidelberg University, University Hospital, Mannheim, Germany
  10. 10Medical Oncology Department, Clínica Universidad de Navarra, Madrid, Program in Solid Tumours, CIMA, Pamplona, and Grupo Español de Investigación en Cáncer de Ovario (GEICO), Pamplona, Spain
  11. 11Department of Gynecological Oncology, Oscar Lambert Center, Lille Cedex, France
  12. 12BC Cancer – Vancouver, Department of Medicine, University of British Columbia, Vancouver, Canada
  13. 13Department of Oncology, UCL Cancer Institute and UCL Hospitals,, London, UK
  14. 14Ovarian Cancer Institute, University Gynecologic Oncology, Atlanta, USA
  15. 15Gynecology Section, Department of Oncology, University Hospital Linköping, Linköping, Sweden
  16. 16Department of Medicine and Surgery, University of Milano-Bicocca, Gynecology Oncology Program European Institute of Oncology, Milan, Italy
  17. 17GSK, Waltham, USA
  18. 18Division of Gynecologic Oncology, HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, USA
  19. 19Division of Gynecologic Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA


Introduction/Background Primary results from the ENGOT-OV16/NOVA study showed that niraparib maintenance therapy significantly prolonged progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of germline BRCA (gBRCA) mutation or homologous recombination deficiency (HRD) biomarker status. Here we report updated final overall survival (OS) and long-term safety results.

Methodology NOVA was a randomised, double-blind, placebo-controlled, phase 3 trial. Patients with PSROC were enroled into independent gBRCA-mutated (gBRCAm) and non-gBRCAm cohorts. Patients were randomised 2:1 to niraparib 300 mg or placebo once daily. Missing survival data for patients were retrieved for the updated analysis (data cutoff: 31 March 2021). Final OS was evaluated in both cohorts and by non-gBRCAm HRD status.

Results 553 patients were randomised. Median follow-up at data cutoff was >75 months across both cohorts and treatment arms. Survival status was available for 97.6% of patients (540/553). Overall OS maturity was 77.9%. Median OS was 40.9 months with niraparib and 38.1 months with placebo in the gBRCAm cohort (hazard ratio, 0.85; 95% CI, 0.61–1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCAm cohort (hazard ratio, 1.06; 95% CI, 0.81–1.37). OS by HRD status is shown in the table 1. No new safety signals were detected. Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) was reported in 14/367 patients (3.8%; 10 [7.4%] gBRCAm, 4 [1.7%] non-gBRCAm) who received niraparib versus 3/179 (1.7%; 2 [3.1%] gBRCAm, 1 [0.9%] non-gBRCAm) placebo patients. There was no evidence suggesting that toxicity, including hematologic events, MDS/AML, or cardiovascular events, contributed to the OS results.

Conclusion After reducing missing data, we provide an updated, exploratory, analysis of NOVA long-term follow-up data. NOVA was not powered to show an OS difference between arms, although the OS hazard ratio numerically favored niraparib in the gBRCAm cohort. No new safety signals were observed with long-term follow-up.

Abstract #161 Table 1

Final OS for the gBRCAm and non-gBRCAm cohorts and by HRD subgroup in the non-gBRCAm cohort.

Disclosures This study was sponsored by GSK, Waltham, MA, USA.

Writing and editorial support, under the direction of the authors, was funded by GSK (Waltham, MA, USA); coordinated by Prudence Roaf, MPH, and Hasan Jamal, MSc, of GSK; and were provided by Betsy C. Taylor, PhD, CMPP, and Dena McWain of Ashfield MedComms, an Inizio company.

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