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Table 3 Phase 3 studies of PARP inhibitors for maintenance therapy in patients with platinum-sensitive ovarian cancer

From: Bringing new medicines to women with epithelial ovarian cancer: what is the unmet medical need?

  Prior lines of chemotherapy Inclusion biomarkers Median PFS, months HR for PFS (95% CI) P value
Active therapy Placebo
Niraparib Monotherapy
 NOVA [38] ≥2 None
Patients stratified according to gBRCA status and HRD score
gBRCA: 21.0 5.5 0.27 (0.17–0.41) <0.001
Non-gBRCA: 9.3 3.9 0.45 (0.34–0.61) <0.001
HRD-positive: 12.9 3.8 0.38 (0.24–0.59) <0.001
HRD-negative: 6.9 3.8 0.58 (0.36–0.92) 0.02
Olaparib Monotherapy
 SOLO-2 [39] ≥2 BRCA1/2 mutation 30.2 5.5 0.25 (0.18–0.35) <0.001
Rucaparib Monotherapy
 ARIEL3 [45, 46] ≥3a None BRCA mutation: 16.6
HRD-positive: 13.6
ITT population: 10.8
5.4
5.4
5.4
0.23
0.32
0.36
<0.001
<0.001
<0.001
  1. CI confidence interval, gBRCA germline BRCA mutation, HR hazard ratio, HRD homologous recombination deficiency, ITT intent-to treat, PARP poly (ADP-ribose) polymerase, PFS progression-free survival
  2. aReceived ≥2 prior platinum-based treatment regimens including platinum based regimen and no more than 1 non-platinum chemotherapy regimen