What is the role of niraparib (Zejula) in the treatment of ovarian cancer?

Updated: Aug 10, 2020
  • Author: Andrew E Green, MD; Chief Editor: Yukio Sonoda, MD  more...
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Niraparib was approved by the FDA in March 2017 for maintenance treatment for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in women who are in complete or partial response to platinum-based chemotherapy. Unlike other PARP inhibitors (eg, olaparib, rucaparib), niraparib is active both in patients with and those without BRCA mutations

.Approval of niraparib was based on results from the placebo-controlled NOVA phase 3 trial (n=553), which showed a significant improvement in PFS with niraparib. In the germline BRCA mutation (gBRCA) cohort, PFS with niraparib versus placebo was 21.0 vs 5.5 months, respectively. PFS was 12.9  vs 3.8 months in the non-gBRCA patients who had tumors with homologous recombination deficiency (HRD), and 9.3  vs 3.9 months in the overall non-gBRCA cohort (P< 0.001 for all 3 comparisons). [110]

The combination of niraparib and pembrolizumab showed promising antitumor activity in an open-label, single-arm phases 1 and 2 study in a 62 patients with recurrent ovarian carcinoma with resistance to or ineligibility for retreatment with a platinum-based chemotherapy regimen.  The objective response rate was was 18% (90% CI, 11%-29%), with a disease control rate of 65% (90% CI, 54%-75%), including 3 patients (5%) with confirmed complete responses, 8 (13%) with confirmed partial responses, and 28 (47%) with stable disease; 20 (33%) experienced progressive disease. [111]

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