Efficacy
After a median follow up of 13.8 months, the median PFS in the HRD population was 21.9 months in the niraparib group vs 10.4 months in the placebo group (HR = 0.43, 95% CI, 0.31 to 0.59, p<0.001). In the overall population, the median PFS was 13.8 months vs 8.2 months respectively (HR = 0.62, 95% CI, 0.50 to 0.76, p<0.001).r
The 2-year OS probability was 84% in the niraparib group and 77% in the placebo group (HR = 0.70, 95% CI, 0.44 to 1.11), signifying no statistically significant OS benefit with niraparib. This outcome was mirrored in the HRD population (91% vs 85% respectively; HR = 0.61, 95% CI, 0.27 to 1.39).
Kaplan-Meier estimates of PFS in the (A) HRD population and (B) overall populationr
© N Engl J Med 2019
In prespecified subgroup analyses, the benefit of niraparib was not only seen in patients with pathogenic BRCA mutations and HRD, but also in homologous recombination proficient (HRP) patients; with a median PFS of 8.1 months in the niraparib group vs 5.4 months in the placebo group (HR = 0.68; 95% CI, 0.49 to 0.94). Niraparib treatment was also favourable in subgroups with poor prognostic factors, including those who received neoadjuvant chemotherapy and those with only a partial response to platinum chemotherapy.
Disease progression or death for prespecified subgroupsr
© N Engl J Med 2019
Patients receiving niraparib did not have significantly different quality-of-life scores to patients receiving placebo as per patient reported outcomes.