Phase III placebo-controlled trials assessing maintenance strategies with single-agent poly (ADP-ribose) polymerase inhibitors (PARPi) after response to platinum-based chemotherapy. Additionally, the three trials in platinum-sensitive settings included patients with ≥2 lines of platinum therapy.
| Trial/PARPi | Histology | BRCA mutation | HRD, excluding BRCA (assay) | Residual disease | CA125 level |
| Front-Line – Switch Maintenance | |||||
| SOLO1 Olaparib | HGS 96% HGE 2% Mixed 2% | Germline 99% Somatic 1% | N/A | N/A | No rising |
| PRIMA Niraparib | HGS 95% HGE 3% Mixed 2% | Germline or somatic 30% | HRD 20% (Myriad Mychoice cut-off: ≥42%) | ≤2 cm | Normal or 90% ↓ with chemotherapy |
| Front-Line – Continuation Maintenance in Three-Arm Design | |||||
| VELIA Veliparib | HGS 100% | Germline 19% Somatic 7% | HRD 29% (Myriad Mychoice cut-off: ≥33%) | N/A | __ |
| Platinum-Sensitive Recurrence – Switch Maintenance (PARPi-Naïve) | |||||
| SOLO2 Olaparib | HGS 91% HGE 6% Mixed 3% | Germline 97% Somatic 0% | N/A | N/A | No rising |
| NOVA Niraparib | Predominantly HGS* | Germline 37% Somatic 8% | HRD 29% (Myriad Mychoice cut-off: ≥42%) | ≤2 cm | Normal or 90% ↓ with chemotherapy |
| ARIEL3 Rucaparib | HGS 95% HGE 4% Mixed 1% | Germline or somatic 35% | LOH high 28% (Foundation medicine T5 cut-off: ≥16%) | N/A | Normal |
*Non-HGS with gBRCAm were also eligible. Number of patients with other histologies has not been reported.
HGE, high-grade endometrioid; HGS, high-grade serous; HRD, homologous recombination deficiency; LOH, loss of heterozygosity; mixed, HGS and HGE; N/A, not applicable; PARPi, poly (ADP-ribose) polymerase inhibitor.