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. 2021 Oct 11;16(6):839–845. doi: 10.1007/s11523-021-00841-2

Table 2.

Efficacy of niraparib in the PRIMA phase III trial

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