NOVA/ENGOT-OV16: trial | Bending the Curve: Trial by Trial

NOVA/ENGOT-OV16

Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer

Population

Platinum-sensitive recurrent ovarian cancer; two cohorts: germline BRCA mutation (203 patients) and non-germline-BRCA (350 patients, of whom a subgroup had tumours with HRD)

Design

Randomised, double-blind phase 3 trial. Patients with platinum-sensitive recurrent ovarian cancer were assigned to a germline BRCA mutation cohort (gBRCA) or a non-gBRCA cohort (by the presence or absence of a germline BRCA mutation and the type of non-gBRCA mutation) and randomised 2:1 to niraparib 300 mg once daily or placebo. Primary end point PFS.

Primary endpoint

PFS

Arms

Niraparib (experimental): Niraparib 300 mg once daily
Placebo (control): Placebo once daily

People

Mirza MR

PFSHR 0.27 (95% CI 0.17–0.41)Δ median PFS+15.5 monthsPFSHR 0.38 (95% CI 0.24–0.59)Δ median PFS+9.1 monthsPFSHR 0.45 (95% CI 0.34–0.61)Δ median PFS+5.4 months

Show the numbers

Results reported for NOVA/ENGOT-OV16
Endpoint	Analysis	Niraparib	Placebo	Effect
PFSGermline BRCA cohort (niraparib n=138, placebo n=65)	primaryMirza 2016	median 21 months	median 5.5 months	HR 0.27 (95% CI 0.17–0.41)P<0.001
PFSNon-gBRCA cohort, tumours with HRD	primaryMirza 2016	median 12.9 months	median 3.8 months	HR 0.38 (95% CI 0.24–0.59)P<0.001Subgroup of the non-gBRCA cohort; the number of patients with HRD is not given in the abstract.
PFSOverall non-gBRCA cohort (niraparib n=234, placebo n=116)	primaryMirza 2016	median 9.3 months	median 3.9 months	HR 0.45 (95% CI 0.34–0.61)P<0.001

Results reported for NOVA/ENGOT-OV16
Endpoint	Analysis	Niraparib	Placebo	Effect
PFSGermline BRCA cohort (niraparib n=138, placebo n=65)	primaryMirza 2016	median 21 months	median 5.5 months	HR 0.27 (95% CI 0.17–0.41)P<0.001
PFSNon-gBRCA cohort, tumours with HRD	primaryMirza 2016	median 12.9 months	median 3.8 months	HR 0.38 (95% CI 0.24–0.59)P<0.001Subgroup of the non-gBRCA cohort; the number of patients with HRD is not given in the abstract.
PFSOverall non-gBRCA cohort (niraparib n=234, placebo n=116)	primaryMirza 2016	median 9.3 months	median 3.9 months	HR 0.45 (95% CI 0.34–0.61)P<0.001

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
PFS	0.27	0.17–0.41
PFS	0.38	0.24–0.59
PFS	0.45	0.34–0.61

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Niraparib (experimental)
Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Niraparib	Placebo
0	100.0%	100.0%
13	65.1%	19.4%
26	42.4%	3.8%
39	27.6%	0.7%
53	17.4%	0.1%

Illustrative — modelled from reported values, not trial data. PFS, primary.

Show curves

Niraparib (experimental)
Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)

Months	Niraparib	Placebo
0	100.0%	100.0%
8	65.1%	23.2%
16	42.3%	5.4%
24	27.5%	1.3%
32	17.9%	0.3%

Appears in

2016 Niraparib and rucaparib maintenance, relapsed disease: NOVA, ARIEL3

Sources

Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer. N Engl J Med. 2016;375(22):2154-2164.
PubMed DOI