Skip to main content

Table 4 Overview of ongoing trials of PARP inhibitors in maintenance

From: Maintenance therapy for recurrent epithelial ovarian cancer: current therapies and future perspectives – a review

Trial name [ClinicalTrials. gov identifier] Drug (approval status) Mono/Combo; Phase; PARP enzymes targeted Patient population; newly diagnosed/recurrent and key eligibility N Treatment arms Primary endpoint Results/Trial status
SOLO-2 (NCT01874353) [51] Olaparib (approved) Mono; Phase III; PARP 1 > PARP2> > PARP3 PSROC HSG; ≥2 PBC BRCAm only, gBRCAmut
BRCA1: Ola:132 (67%)
PBO: 61 (62%)
BRCA2: Ola: 58 (30%)
PBO: 35 (35%)
295 Olaparib 300 mg bid vs placebo maintenance after ≥2 PBC PFS Ola vs PBO: 19.3 months (95% CI 16.5–27.3) vs 5.5 months (5.0–5.8); HR [in favor of ola] 0.33, 95% CI 0.24–0.44; p < 0.0001).; study completion 2021
SOLO1 (NCT01844986) [11, 65] Olaparib (approved) Mono; Phase III; PARP 1 > PARP2> > PARP3 Germline BRCA mutant only, newly diagnosed HGSOC or endometrioid stage III and IV
Of 391 patients at interim analysis, centrally confirmed gBRCA1/2 m: 388 somatic BRCA1/2 m: 2
451 Olaparib 300 mg bid vs placebo maintenance after 1 L PBC PFS Primary analysis: 60% vs. 27% in ola vs PBO (HR for disease progression or death, 0.30; 95% CI, 0.23 to 0.41; p < 0.001)
Ongoing; study completion 2023
PAOLA1/ENGOT/GCIG (NCT02477644) [66] Olaparib (approved) Combo; Phase III; PARP 1 > PARP2> > PARP3 Newly diagnosed HGSOC 612 Bev or bev/olaparib maintenance after 1 L platinum/taxane/bev PFS Ongoing; study completion 2022
ICON 9 trial (NCT03278717) Olaparib (approved) Combo; Phase III; PARP 1 > PARP2> > PARP3 PSROC 618 Olaparib or olaparib/cediranib maintenance after 1 L PBC PFS and OS Ongoing; study completion 2023
ENGOT-OV26/PRIMA (NCT02655016) [67] Niraparib (approved) Mono; Phase III; PARP1 and PARP2 HRD positive, stage III and IV 305 Niraparib vs placebo maintenance after 1 L PBC with PR or CR PFS Ongoing; study completion August 2019
GOG-3005 (NCT02470585) [11] Velaparib (investigational) Combo; Phase III; PARP 1and PARP2 Advanced HGSOC, both BRCA germline mutation carriers and BRCA wild types 1140 Veliparib vs placebo maintenance after 1 L (C + Pac) or (C + Pac + veliparib) PFS Ongoing; study completion 2020
  1. PARPi Poly ADP-ribose polymerase inhibitor, C carboplatin, bev Bevacizumab, Pac paclitaxel, PLD pegylated liposomal doxorubicin, PBC platinum-based chemotherapy, 1 L first-line, N patient accural, wt wild-type BRCA, gBRCAm BRCA germline mutation carrier, BRCAm BRCA mutant, PFS progression free survival, ORR overall response rate, OS overall survival, HGSOC high-grade serous ovarian cancer, PSROC platinum sensitive recurrent ovarian cancer, HRD homologous recombination deficiency, HR hazard ratio, CI confidence interval, bid twice daily, od once daily, nira niraparib, ruca rucaparib, PBO placebo, PR partial response, CR complete response