Niraparib in patients with newly diagnosed advanced ovarian cancer

A. González-Martín, B. Pothuri, I. Vergote, R. DePont Christensen, W. Graybill, M. R. Mirza, C. McCormick, D. Lorusso, P. Hoskins, G. Freyer, K. Baumann, K. Jardon, A. Redondo, R. G. Moore, C. Vulsteke, R. E. O'Cearbhaill, B. Lund, F. Backes, P. Barretina-Ginesta, A. F. HaggertyM. J. Rubio-Pérez, M. S. Shahin, G. Mangili, W. H. Bradley, I. Bruchim, K. Sun, I. A. Malinowska, Y. Li, D. Gupta, B. J. Monk

Research output: Contribution to journalArticlepeer-review


BACKGROUND: Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to firstline platinum-based chemotherapy is unknown. METHODS: In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival. RESULTS: Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred. CONCLUSIONS: Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency.

Original languageEnglish
Pages (from-to)2391-2402
Number of pages12
JournalNew England Journal of Medicine
Issue number25
Publication statusPublished - Dec 19 2019

ASJC Scopus subject areas

  • Medicine(all)


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