ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation...

Newly Diagnosed Ovarian Cancer….Recommendation 2.1...For those with germline or somatic pathogenic or likely pathogenic variants in BRCA1 or BRCA2 genes, options should include olaparib (300 mg orally every 12 hours for 2 years), niraparib (200-300 mg orally daily for 3 years) or rucaparib (600 mg twice a day for 2 years).

Recurrent Ovarian Cancer: Second-Line or Greater Maintenance and Treatment...Treatment with a PARPi should be offered to patients with recurrent EOC who have not already received a PARPi and have a germline or somatic pathogenic or likely pathogenic variants in BRCA1 or BRCA2 genes....Options include:....niraparib 200-300 mg once daily...

PARP inhibitors (olaparib, niraparib and rucaparib) when given as maintenance therapy following a response to platinum-based second or higher line of treatment have proven benefit with respect to PFS and could be recommended. The benefit is greatest in, but is not limited to, patients with a BRCA mutation.

Niraparib has been added to the maintenance therapy options for those with complete or partial remission (CR/PR), if:…Germline or somatic BRCA1/2 mutation...

The BRCAm populations from each trial are as follows: 223 (148 BRCA1m and 75 BRCA2m) from the PRIMA trial, 203 (128 BRCA1m, 69 BRCA2m, and 13 BRCA1/2m) from the NOVA trial, and 100 (78 BRCA1m, 21 BRCA2m, and 1 BRCA1/2m) from the NORA trial...Patients with BRCAm OC derived a significant PFS benefit from niraparib maintenance treatment across all 3 trials.

Of the 265 patients enrolled, 133 (50.2%) achieved a CR (niraparib, n = 86; placebo, n = 47), and 131 (49.4%) achieved a PR (niraparib, n = 90; placebo, n = 41) to the last platinum-based chemotherapy . At baseline, among patients with a CR or PR, 64.7% (86/133) and 71.8% (94/131) had FIGO Stage IIIC or IV disease at initial diagnosis and 43.6% (58/133) and 32.1% (42/131) had germline BRCA mutations, respectively . Niraparib treatment led to a longer median PFS versus placebo in both the CR (NR vs 5.75 months; HR = 0.26; 95% CI, 0.15-0.45, p < 0.0001) and PR (8.54 vs . 3.68 months; HR = 0.33; 95% CI, 0.21- 0.52, p < 0.0001) groups, and provided a PFS benefit among patients with a CR or PR regardless of germline BRCA mutation status...Of the patients enrolled in the NORA trial, 50.2% achieved a CR to the last platinum-based chemotherapy. Compared with placebo, niraparib maintenance therapy provided a PFS benefit to patients with a CR or PR, regardless of germline BRCA mutation status, and was generally well tolerated.

Eligible patients were women aged ≥18 years with PSROC who had either germline BRCA mutation or high-grade serous histologic features...249 patients (median body weight 61kg) received the individualized dosing of niraparib/placebo. Patients in the niraparib group had a significantly longer median PFS than did those in the placebo group, 18.3 vs. 5.4 months (HR=0.30; 95% CI, 0.21–0.43).

...Eligible patients were women with PSROC who had either germline BRCA mutation….The median PFS was significantly longer for patients on niraparib versus placebo; 18.3 (95% CI, 10.9, not evaluable) versus 5.4 (95% CI, 3.7, 5.7) months....ISD of niraparib is effective and safe...

The median duration of progression-free survival in patients with homologous-recombination deficiency was 21.9 months with niraparib and 10.4 months with placebo (hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001)...Within the population with homologous-recombination deficiency, the median duration of progression-free survival was 22.1 months in the niraparib group and 10.9 months in the placebo group (hazard ratio, 0.40; 95% CI, 0.27 to 0.62) in the subgroup with BRCA mutations and 19.6 months and 8.2 months, respectively (hazard ratio, 0.50; 95% CI, 0.31 to 0.83), in the subgroup without BRCA mutations....

Patients in the niraparib group had a significantly longer median duration of progression-free survival than did those in the placebo group, including 21.0 vs. 5.5 months in the gBRCA cohort (hazard ratio, 0.27; 95% confidence interval [CI], 0.17 to 0.41), as compared with 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD) (hazard ratio, 0.38; 95% CI, 0.24 to 0.59) and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (hazard ratio, 0.45; 95% CI, 0.34 to 0.61; P<0.001 for all three comparisons).

...Los participantes con mutaciones deletéreas o presuntas mutaciones deletéreas en la línea germinal de BRCA1/2 mediante una prueba aprobada (por ejemplo, BRACAnalysis CDx) serán elegibles, pero requerirán una prueba central de DRH. ...

...- Diagnosis of triple negative breast cancer or ovarian cancer, or any cancer histology with the presence of alteration in BRCA1, BRCA2, PARP metabolism, DNA repair pathways and HRD (homologous recombination deficiency) genes in the metastatic site as described in Section 9.2 using a CLIA-certified assay....

...Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation....

...BRCA1/2 gene mutation or HRD was confirmed by tissue or blood samples detected by the testing institution designated by the research center; 5....

The PFS rates of 199 patients at 6, 12, 18, 24, and 30 months were 87.4%, 75.9%, 63.6%, 56.1%, and 51.8%, respectively. LASSO regression model revealed that only age < 65 years (P = 0.011), BRCA mutations (P < 0.001), and R0 status after cytoreductive surgery (P = 0.01) were significant factors associated with prolonged PFS times...For Chinese OC patients, niraparib, particularly at a 200 mg individual starting dose, was an effective therapy with easily manageable safety.

In the patients received treatment of PARP inhibitor Niraparib, carriers of germline and somatic pathogenic variant in BRCA1 and BRCA1/2 were more sensitive to Niraparib (p value: 0.18, 0.008)…

We included HGSOC p treated with ssq CT after progression to maintenance PARPi...56p were identified (32p BRCAmut; 1p BRIP1mut). 4p (7.1%) received PARPi after 1st line CT, 26 (46.4%) after 2nd line and 26 (46.4%) after ≥3rd line. 34p (60.7%) received olaparib and 22 (39.3%) niraparib...m-PARPi-PFS in the recurrent setting was 7.5 mo (longer in BRCAmut: 10.1 vs 5.5 mo, p 0.03). m-PARPi-PFS2 was 15.8 mo (longer in BRCAmut: 20.9 vs 15.4 mo, p 0.07).

Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort…