Abstract
<div><p>In this analysis, we examined the relationship between progression-free survival (PFS) and mutation status of 18 homologous recombination repair (HRR) genes in patients in the non-germline <i>BRCA</i>-mutated (non-g<i>BRCA</i>m) cohort of the ENGOT-OV16/NOVA trial (NCT01847274), which evaluated niraparib maintenance therapy for patients with recurrent ovarian cancer. This <i>post hoc</i> exploratory biomarker analysis was performed using tumor samples collected from 331 patients enrolled in the phase III ENGOT-OV16/NOVA trial's non-g<i>BRCA</i>m cohort. Niraparib demonstrated PFS benefit in patients with either somatic <i>BRCA-</i>mutated (s<i>BRCA</i>m; HR, 0.27; 95% confidence interval, CI, 0.08–0.88) or <i>BRCA</i> wild-type (<i>BRCA</i>wt; HR, 0.47; 95% CI, 0.34–0.64) tumors. Patients with <i>BRCA</i>wt tumors with other non-<i>BRCA</i> HRR mutations also derived benefit from niraparib (HR, 0.31; 95% CI, 0.13–0.77), as did patients with <i>BRCA</i>wt/HRRwt (HRR wild-type) tumors (HR, 0.49; 95% CI, 0.35–0.70). When patients with <i>BRCA</i>wt/HRRwt tumors were further categorized by genomic instability score (GIS), clinical benefit was observed in patients with homologous recombination–deficient (GIS ≥ 42; HR, 0.33; 95% CI, 0.18–0.61) and in patients with homologous recombination–proficient (HRp; GIS < 42; HR, 0.60; 95% CI, 0.36–0.99) disease. Although patients with s<i>BRCA</i>m, other non-<i>BRCA</i> HRR mutations, or GIS ≥ 42 benefited the most from niraparib treatment, PFS benefit was also seen in HRp (GIS < 42) patients without HRR mutations. These results support the use of niraparib in patients with recurrent ovarian cancer regardless of <i>BRCA</i>/HRR mutation status or myChoice CDx GIS.</p>Significance:<p>We retrospectively evaluated the mutational profile of HRR genes in tumor samples from 331 patients from the non-germline <i>BRCA</i>-mutated cohort of the phase III NOVA trial of patients with platinum-sensitive high-grade serous ovarian cancer. Patients with non-<i>BRCA</i> HRR mutations generally benefited from second-line maintenance treatment with niraparib compared with placebo.</p></div>
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