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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