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

ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety. Gynecologic oncology Matulonis, U. A., Herrstedt, J., Oza, A., Mahner, S., Redondo, A., Berton, D., Berek, J. S., Haslund, C. A., Marme, F., Gonzalez-Martin, A., Becourt, S., Tinker, A. V., Ledermann, J. A., Benigno, B., Lindahl, G., Colombo, N., Malinowska, I. A., Liu, W., Bains, M., Monk, B. J., Mirza, M. R. 2025; 195: 192-199

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.

View details for DOI 10.1016/j.ygyno.2025.03.018

View details for PubMedID 40139026