ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety

Ursula A Matulonis; Jørn Herrstedt; Amit Oza; Sven Mahner; Andrés Redondo; Dominique Berton; Jonathan S Berek; Charlotte A Haslund; Frederik Marmé; Antonio González-Martín; Stéphanie Bécourt; Anna V Tinker; Jonathan A Ledermann; Benedict Benigno; Gabriel Lindahl; Nicoletta Colombo; Izabela A Malinowska; Wenlei Liu; Manjinder Bains; Bradley J Monk; Mansoor R Mirza

doi:10.1016/j.ygyno.2025.03.018

ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety

Ursula A Matulonis^*, Jørn Herrstedt, Amit Oza, Sven Mahner, Andrés Redondo, Dominique Berton, Jonathan S Berek, Charlotte A Haslund, Frederik Marmé, Antonio González-Martín, Stéphanie Bécourt, Anna V Tinker, Jonathan A Ledermann, Benedict Benigno, Gabriel Lindahl, Nicoletta Colombo, Izabela A Malinowska, Wenlei Liu, Manjinder Bains, Bradley J MonkMansoor R Mirza

^*Corresponding author for this work

Department of Oncology

7 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.

METHODS: Patients were randomized 2:1 to niraparib (300 mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021).

RESULTS: Survival status was available for 97.6% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA-mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1 months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCA-mutated cohort (HR, 1.06; 95% CI, 0.81-1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected.

CONCLUSIONS: OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit-risk profile for niraparib in the recurrent OC maintenance setting.

Original language	English
Journal	Gynecologic Oncology
Volume	195
Pages (from-to)	192-199
Number of pages	8
ISSN	0090-8258
DOIs	https://doi.org/10.1016/j.ygyno.2025.03.018
Publication status	Published - 2025

Keywords

Maintenance
Niraparib
Ovarian cancer
Platinum sensitive recurrence

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10.1016/j.ygyno.2025.03.018

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Matulonis, U. A., Herrstedt, J., Oza, A., Mahner, S., Redondo, A., Berton, D., Berek, J. S., Haslund, C. A., Marmé, F., González-Martín, A., Bécourt, S., Tinker, A. V., Ledermann, J. A., Benigno, B., Lindahl, G., Colombo, N., Malinowska, I. A., Liu, W., Bains, M., ... Mirza, M. R. (2025). ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety. Gynecologic Oncology, 195, 192-199. https://doi.org/10.1016/j.ygyno.2025.03.018

Matulonis, UA, Herrstedt, J, Oza, A, Mahner, S, Redondo, A, Berton, D, Berek, JS, Haslund, CA, Marmé, F, González-Martín, A, Bécourt, S, Tinker, AV, Ledermann, JA, Benigno, B, Lindahl, G, Colombo, N, Malinowska, IA, Liu, W, Bains, M, Monk, BJ & Mirza, MR 2025, 'ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety', Gynecologic Oncology, vol. 195, pp. 192-199. https://doi.org/10.1016/j.ygyno.2025.03.018

@article{6031f00d86b14bd9a031769b0e37e307,

title = "ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety",

abstract = "OBJECTIVE: To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.METHODS: Patients were randomized 2:1 to niraparib (300 mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021).RESULTS: Survival status was available for 97.6\% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA-mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1 months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95\% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCA-mutated cohort (HR, 1.06; 95\% CI, 0.81-1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected.CONCLUSIONS: OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit-risk profile for niraparib in the recurrent OC maintenance setting.",

keywords = "Maintenance, Niraparib, Ovarian cancer, Platinum sensitive recurrence",

author = "Matulonis, \{Ursula A\} and J{\o}rn Herrstedt and Amit Oza and Sven Mahner and Andr{\'e}s Redondo and Dominique Berton and Berek, \{Jonathan S\} and Haslund, \{Charlotte A\} and Frederik Marm{\'e} and Antonio Gonz{\'a}lez-Mart{\'i}n and St{\'e}phanie B{\'e}court and Tinker, \{Anna V\} and Ledermann, \{Jonathan A\} and Benedict Benigno and Gabriel Lindahl and Nicoletta Colombo and Malinowska, \{Izabela A\} and Wenlei Liu and Manjinder Bains and Monk, \{Bradley J\} and Mirza, \{Mansoor R\}",

note = "Copyright {\textcopyright} 2025. Published by Elsevier Inc.",

year = "2025",

doi = "10.1016/j.ygyno.2025.03.018",

language = "English",

volume = "195",

pages = "192--199",

journal = "Gynecologic Oncology",

issn = "0090-8258",

publisher = "Academic Press Inc.",

}

TY - JOUR

T1 - ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer

T2 - Survival and long-term safety

AU - Matulonis, Ursula A

AU - Herrstedt, Jørn

AU - Oza, Amit

AU - Mahner, Sven

AU - Redondo, Andrés

AU - Berton, Dominique

AU - Berek, Jonathan S

AU - Haslund, Charlotte A

AU - Marmé, Frederik

AU - González-Martín, Antonio

AU - Bécourt, Stéphanie

AU - Tinker, Anna V

AU - Ledermann, Jonathan A

AU - Benigno, Benedict

AU - Lindahl, Gabriel

AU - Colombo, Nicoletta

AU - Malinowska, Izabela A

AU - Liu, Wenlei

AU - Bains, Manjinder

AU - Monk, Bradley J

AU - Mirza, Mansoor R

PY - 2025

Y1 - 2025

N2 - OBJECTIVE: To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.METHODS: Patients were randomized 2:1 to niraparib (300 mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021).RESULTS: Survival status was available for 97.6% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA-mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1 months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCA-mutated cohort (HR, 1.06; 95% CI, 0.81-1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected.CONCLUSIONS: OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit-risk profile for niraparib in the recurrent OC maintenance setting.

AB - OBJECTIVE: To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.METHODS: Patients were randomized 2:1 to niraparib (300 mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021).RESULTS: Survival status was available for 97.6% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA-mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1 months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCA-mutated cohort (HR, 1.06; 95% CI, 0.81-1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected.CONCLUSIONS: OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit-risk profile for niraparib in the recurrent OC maintenance setting.

KW - Maintenance

KW - Niraparib

KW - Ovarian cancer

KW - Platinum sensitive recurrence

UR - https://www.scopus.com/pages/publications/105000806121

U2 - 10.1016/j.ygyno.2025.03.018

DO - 10.1016/j.ygyno.2025.03.018

M3 - Journal article

C2 - 40139026

SN - 0090-8258

VL - 195

SP - 192

EP - 199

JO - Gynecologic Oncology

JF - Gynecologic Oncology

ER -

ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety

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Keywords

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