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

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 maintenanc...

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Main Authors: Matulonis, Ursula A. (Author) , Herrstedt, Jørn (Author) , Oza, Amit (Author) , Mahner, Sven (Author) , Redondo, Andrés (Author) , Berton, Dominique (Author) , Berek, Jonathan S. (Author) , Haslund, Charlotte A. (Author) , Marmé, Frederik (Author) , González-Martín, Antonio (Author) , Bécourt, Stéphanie (Author) , Tinker, Anna V. (Author) , Ledermann, Jonathan A. (Author) , Benigno, Benedict (Author) , Lindahl, Gabriel (Author) , Colombo, Nicoletta (Author) , Malinowska, Izabela A. (Author) , Liu, Wenlei (Author) , Bains, Manjinder (Author) , Monk, Bradley J. (Author) , Mirza, Mansoor R. (Author)
Format: Article (Journal)
Language:English
Published: April 2025
In: Gynecologic oncology
Year: 2025, Volume: 195, Pages: 192-199
ISSN:1095-6859
DOI:10.1016/j.ygyno.2025.03.018
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ygyno.2025.03.018
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0090825825000873
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Author Notes: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
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Summary: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 (300mg 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 38.1months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61-1.20) and 31.0 and 34.8months, 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.
Item Description:Online veröffentlicht: 25. März 2025, Artikelversion: 25. März 2025
Gesehen am 23.06.2025
Physical Description:Online Resource
ISSN:1095-6859
DOI:10.1016/j.ygyno.2025.03.018

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