TABLE 6.

Clinical trials with niraparib in ovarian cancer.

Name of the study	Year of the study	Phase of the study	Research group	Dose of niraparib	Results
ENGOT-OV16/NOVA (Mirza et al., 2016)	2016	III	553 patients: 203 patients in the gBRCA cohort (niraparib group n = 138, placebo group n = 65), 350 patients in the non-gBRCA cohort (niraparib group n = 234, placebo group n = 116)	300 mg once daily	Niraparib group, placebo group: gBRCA cohort - PFS 21.0, 5.5 months; non-gBRCA cohort - PFS 12.9, 3.8 months, respectively
NORA trial (NCT03705156) (Wu et al., 2021)	2021	III	265, (niraparib group n = 177, placebo group n = 88)	300 mg/day or 200 mg/day (depending on bodyweight and platelet count)	Niraparib group, placebo group: PFS 18.3, 5.4 months, TFST 16.7, 7.7 months, respectively
PRIMA/ENGOT-OV26/GOG-3012 (González-Martín et al., 2023)	2023	III	733, (niraparib group n = 487, placebo group n = 246)	300 mg/day or 200 mg/day (depending on bodyweight and platelet count)	Niraparib group, placebo group: overall population - PFS 13.8, 8.2 months; HRd population - PFS 24.5, 11.2 months; HRp population - 8.4, 5.4 months, respectively
Li et al. (Li et al., 2023)	2023	III	384, (niraparib group n = 255, placebo group n = 129)	300 mg/day or 200 mg/day (depending on bodyweight and platelet count)	Niraparib group, placebo group: PFS 24.8, 8.3 months, respectively

gBRCA, germline BRCA, mutation; PFS, progression-free survival; TFST, time to first subsequent therapy or death; HR, homologous recombination deficiency status (HRd, deficient; HRp, proficient or not determined).