A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID # NCT02446600; NRG-GY004
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Carboplatin, Cediranib, Liposomal doxorubicin, Olaparib, Paclitaxel, Gemcitabine
Eligible Participant

Platinum sensitive high grade serous or endometrioid ovarian cancer or germline BRCA1/2-mutated ovarian cancer, no prior PARP inhibitor

Patients Enrolled

565, median 1 prior therapy

Therapy Setting


Study Design

Open-Label, Randomized


ORR, PFS, OS, evaluated per RECIST


Exploratory: BROCA-HR


Ola+Ced (n=189) vs Ola (n=189) vs Treatment of Physician's Choice (TPC) (CarboPt+Gem (27%)/PLD (48%)/Pac (25%), n=187):

ORR: 69.4 vs 52.4 vs 71.3%
PFS: 10.4 vs 8.2 vs 10.3 months, HR: 0.86 (0.66-1.11, p=0.077); HR: 1.20 (0.93-1.54)
OS: 33.5 vs 31.0 vs 32.7 months

Exploratory analysis, gBRCA status, HRR status, LOH status:
gBRCA MUT: ORR: 89 vs 90 vs 71%; PFS: 18.0 vs 12.7 vs 10.5 months, HR: 0.55 (0.32-0.94); HR: 0.63 (0.37-1.07)
gBRCA WT: ORR: 64 vs 40 vs 72%; PFS: 8.9 vs 6.6 vs 9.7 months, HR: 0.97 (0.73-1.30); HR: 1.41 (1.07-1.81)
HRR mut: PFS: 20.4 vs 13.1 vs 12.3 months, HR: 0.55 (0.32-0.95); HR0.78 (0.48-1.27)
HRR wt: PFS: 8.5 vs 6.4 vs 9 months, HR: 0.93 (0.68-1.27); HR1.56 (1.15-2.12) 
LOH high: PFS: 12.2 vs 8.5 vs 10.6 months
LOH low: PFS: 8.4 vs 6.3 vs 8.1 months

Clinically Significant Adverse Events

Ola+Ced vs Ola vs TPC:
Serious AE:
Grade 3-4 AE: neutropenia (3.8 vs 1.6 vs 31.8%), anemia (5.5 vs.15.0 vs 13.8%), thrombocytopenia (1.6 vs 1.0 vs 15.0%), leukopenia (1.1 vs 1.1 vs 14.4%), fatigue (17.5 vs 7.0 vs 1.8%), diarrhea (13.7 vs 1.0 vs 1.8%), hypertension (31.7 vs 5.3 vs 1.8%)


Cediranib+olaparib has similar activity to standard of care in relapsed platinum sensitive ovarian cancer but does not improve PFS or OS


Liu J et al. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial. J Clin Oncol (2022) 40(19):2138-2147

Liu JF et al. Overall survival (OS) outcomes from NRG-GY004, a phase III study comparing single-agent olaparib or combination cediranib and olaparib to platinum (Plat) based chemotherapy in recurrent plat sensitive ovarian cancer (OvCa). Ann Oncol (2023) 34(2) abstract LBA45

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