Table 2.
HRd population | Overall population | |||
---|---|---|---|---|
NIR (n = 247) | PL (n = 126) | NIR (n = 487) | PL (n = 246) | |
Median PFSa [mo] (HR; 95% CI) | 21.9 (0.43; 0.31–0.59)* | 10.4 | 13.8 (0.62; 0.50–0.76)* | 8.2 |
24-mo survivalb [%] (HR; 95% CI) | 91 (0.61; 0.27–1.39) | 85 | 84 (0.70;0.44–1.11) | 77 |
Median follow-up duration at data cut-off (17 May 2019) was 13.8 mo and disease progression or death occurred in 154 patients in the HRd population and 386 patients in the overall population. Analyses were carried out in intention-to-treat populations [11].
HR hazard ratio, HRd patients who were homologous-recombination deficiency positive, mo months, NIR niraparib, PFS progression-free survival, PL placebo
*p < 0.001 vs PL
aPrimary endpoint
bEstimated Kaplan–Meier probability of overall survival