Background: Niraparib has been approved for the maintenance treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer after front-line chemotherapy (CT) and in the recurrent setting. Here, we summarize niraparib efficacy and safety in patients with BRCAm OC across three phase 3 trials: PRIMA/ENGOT-OV26/GOG-3012 (PRIMA; NCT02655016), ENGOT-OV16/NOVA (NOVA; NCT01847274), and NORA (NCT03705156). Methods: Patients enrolled in the PRIMA trial had newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer. All patients had stage III or IV high-grade serous or endometrioid tumors and had a complete or partial response to their first-line platinum-based CT treatment. Subgroup analysis by tumor BRCAm status was prespecified. Patients enrolled in the NOVA and NORA studies had platinum-sensitive, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. Patients had already received at least 2 lines of platinum-based CT regimens. In both studies, subgroup analysis by germline BRCAm status was prespecified. The primary endpoint in all trials was progression-free survival (PFS) by blinded independent central review. Results: 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. PFS results are shown in the Table. Across the 3 trials, the most common treatment-emergent adverse events were thrombocytopenia, anemia, neutropenia, and hypertension. Conclusions: Patients with BRCAm OC derived a significant PFS benefit from niraparib maintenance treatment across all 3 trials. No new safety signals were identified. Clinical trial information: NCT02655016, NCT01847274, NCT03705156

^aBRCA1 and BRCA2 data are not currently available.FSD, fixed starting dose; gBRCAm, germline BRCA mutated; HR, hazard ratio; ISD, individualized starting dose; mPFS, median progression-free survival; NR, not reached.