A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer (NOVA)

Trial ID # NCT01847274; NOVA
Phase III
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Niraparib
Alternate Drug Names MK4827, Zejula
Drugs in Trial Niraparib
Eligible Participant

Platinum sensitive recurrence and CR or PR in most recent platinum-based therapy, ≥ 2 platinum-based regimens

Patients Enrolled


Therapy Setting


Study Design

Double Blind, Randomized


PFS, OS, PFS2, evaluated per RECIST


Exploratory: BRCA1/2, HRD status (myChoice HRD test, Myriad Genetics), 43-gene NGS assay (Myriad Genetics)


Nir maint vs Placebo (BICR):

non-gBRCA MUT (n=350):
PFS: 9.3 vs 3.9 months, HR: 0.45 (0.34-0.61, p<0.001)
PFS2: HR: 0.81 (0.62-1.05)
OS: 31 vs 34.8 months, HR: 1.06 (0.81-1.37)

gBRCA MUT (n=203):
PFS: 21.0 vs 5.5 months, HR: 0.27 (0.17-0.41, p<0.001)
PFS2: HR: 0.67 (0.48-0.95)
HRD+ (excl. gBRCA MUT) (n=162):
PFS: 12.9 vs 3.8 months, HR: 0.38 (0.24-0.59, p<0.001)
OS: 40.9 vs 38.1 months, HR: 0.85 (0.61-1.20)

Exploratory analysis HRD status, sBRCA status, all non-gBRCA MUT, response after chemo:
HRD+ (excl. gBRCA MUT, excl. sBRCA MUT) (n=115): PFS: 9.3 vs 3.7 months, HR: 0.38 (0.23-0.63, p<0.001)
HRD+ (excl. gBRCA MUT, incl. sBRCA MUT) (n=47): PFS: 20.9 vs 11.0 months, HR: 0.27 (0.08-0.90, p=0.02)
HRD- (n=134): PFS: 6.9 vs 3.8 months, HR: 0.58 (0.36-0.92, p=0.02)
gBRCA MUT, CR after chemo: HR: 0.30 (0.16-0.55, p<0.0001)
gBRCA MUT, PR after chemo: HR: 0.26 (0.13-0.44, p<0.0001)
Non-gBRCA MUT, CR after chemo: HR: 0.58 (0.38-0.87, p=0.0082)
Non-gBRCA MUT, PR after chemo: HR: 0. 35 (0.23-0.53, p<0.0001)

Clinically Significant Adverse Events

Nir vs Placebo:
Serious AE: MDS/AML: (3.8 vs 1.7%), 6.6% of gBRCA MUT patients in Niraparib arm
Grade 3-4 AE: any (74.1 vs 22.9%), thrombocytopenia (33.8 vs 0.6%), anemia (25.3 vs 0%), neutropenia (19.6 vs 1.7%), fatigue (8.2 vs 0.6%), hypertension (8.2 vs 2.2%)


Improved PFS for non-gBRCA MUT patients with niraparib maintenance, but no OS benefit


Mirza MB et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med (2016) 375(22): 2154-2164

Del Campo JM et al. Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial. J Clin Oncol (2019) 37(32):2968-2973

Matulonis U et al. Long-term safety and secondary efficacy endpoints in the ENGOT-OV16/NOVA phase III trial of niraparib in recurrent ovarian cancer. SGO (2021) abstract 11139

Matulonis UA et al. Final overall survival and long-term safety in the ENGOT-OV16/NOVA phase III trial of niraparib in patients with recurrent ovarian cancer. SGO (2023) abstract 6

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