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Table 3 Overview of PARP inhibitor trials in EOC Treatment

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

Trial name [ClinicalTrials.gov identifier]s

PARPi (approval status)

Mono/Combo; Phase; PARP enzyme targeted

Patient population and key eligibility

N

Treatment arms

Primary endpoint

Results/Trial status

Study 42 (NCT01078662) [56]

Olaparib (approved)

Mono;

PARP 1 > PARP2> > PARP3

Confirmed genetic BRCA1 and/or BRCA2 mutation

298

Olaparib 400 mg (8 × 50 mg capsules), oral BID until progression of the disease

Tumor response rate

ORR was 34% (46/137; 95% CI: 26–42) and median DoR was 7.9 (95% CI 5.6–9.6) months

LIGHT study (NCT02983799) [57]

Olaparib (approved)

PARP 1 > PARP2> > PARP3

gBRCAm and wt PSROC HGS

260

Olaparib 300 mg after ≥1 L PBC

ORR

Ongoing; study completion 2020

SOLO3/ NCT02282020 [11]

Olaparib (approved)

Mono; Phase III; PARP 1 > PARP2> > PARP3

gBRCAm PSROC

411

Olaparib vs. physician’s choice of single agent standard of care non-platinum based chemotherapy (TPC) after ≥2 L PBC

ORR

ORR 72% olaparib vs 51% TPC OR 2.53 (1.40, 4.58)

p = 0.002

PFS 13.4 vs 9.2 mo

HR 0.62 (0.43, 0.91);

P = 0.013

NCT01081951

Olaparib (approved)

Combo; Phase II; PARP 1 > PARP2> > PARP3

PSROC (both germline BRCA and sporadic)

162

200 or 400 mg BID olaparib + C + Pac vs C + Pac as first line

PFS

Prelim results: Median PFS 12.2 (olaparib arm) versus 9.6 mos (no olaparib) p = 0.0012; study completion Dec 2018

NRG-GY005 (NCT0250226)

Olaparib (approved)

Combo; Phase II/III; PARP 1 > PARP2> > PARP3

Platinum resistant recurrent high-grade

OC

680

Olaparib/cediranib versus single agent chemotherapy

PFS (phase II)

OS (phase III)

Ongoing; study completion 2023

NCI-OVM1403/NRG-GY004 (NCT0244660)

Olaparib (approved)

Combo; Phase III; PARP 1 > PARP2> > PARP3

PSROC HGS; BRCA stratified

549

Olaparib versus olaparib/cediranib versus platinum doublet

PFS

Ongoing; study completion Dec 2019

ENGOTOV24/AVANOVA (NCT02354131)

Niraparib (investigational; approved only for maintenance)

Combo; Phase I/II; PARP1 and PARP2

PSROC

108

Niraparib versus niraparib-bevacizumab

PFS

Ongoing; study completion 2020

ARIEL 2 (Part 1: results available; Part 2 ongoing) (NCT01891344) [53]

Rucaparib (approved)

PARP 1>>>> > PARP2

PSROC HGS

493

600 mg BID rucaparib

PFS

Prelim results: PFS in the BRCAm (HR 0.27, 95% CI 0.16–0.44, p < 0.0001) LOH high (0.62, 0.42–0.90, p = 0.011)

ARIEL4/NCT02855944

Rucaparib (approved)

Mono; Phase III; PARP 1>>>> > PARP2

BRCAm HGSOC (platinum sensitive and resistant)

345

Rucaparib vs PBC

PFS

Ongoing; study completion 2024

NCT01113957

Veliparib (investigational)

Combo; PARP 1 and PARP2

Recurrent HGSOC (both germline BRCA and sporadic allowed)

168

[1] Veliparib and temozolomide vs.

[2] PLD

ORR

Results not available

NCT01306032 [58]

Veliparib (investigational)

Combo; PARP 1 and PARP2

Recurrent HGSOC (both germline BRCA and sporadic allowed)

75

Oral cyclophos 50 mg + veliparib 60 mg daily vs. Oral cyclophos 50 mg daily

ORR

Well tolerated with some clinical activity; addition of veliparib at 60 mg daily did not improve either the response rate or the median PFS

  1. PARPi: Poly ADP-ribose polymerase inhibitor; PLD: pegylated liposomal doxorubicin; Cyclophos: cyclophosphamide; CI: confidence interval; DoR: duration of response; N: patient accural; wt: wild-type BRCA; gBRCAm: BRCA germline mutation carrier; BRCAm: BRCA mutant; PFS: progression free survival; ORR: overall response rate; HGSOC: high-grade serous ovarian cancer; PSROC: platinum sensitive recurrent ovarian cancer; HR: hazard ratio