Introduction/Background Primary results from the ENGOT-OV16/NOVA study showed that niraparib maintenance therapy significantly prolonged progression-free survival (PFS) in patients with platinum-sensitive recurrent ovarian cancer (PSROC) regardless of germline BRCA (gBRCA) mutation or homologous recombination deficiency (HRD) biomarker status. Here we report updated final overall survival (OS) and long-term safety results.
Methodology NOVA was a randomised, double-blind, placebo-controlled, phase 3 trial. Patients with PSROC were enroled into independent gBRCA-mutated (gBRCAm) and non-gBRCAm cohorts. Patients were randomised 2:1 to niraparib 300 mg or placebo once daily. Missing survival data for patients were retrieved for the updated analysis (data cutoff: 31 March 2021). Final OS was evaluated in both cohorts and by non-gBRCAm HRD status.
Results 553 patients were randomised. Median follow-up at data cutoff was >75 months across both cohorts and treatment arms. Survival status was available for 97.6% of patients (540/553). Overall OS maturity was 77.9%. Median OS was 40.9 months with niraparib and 38.1 months with placebo in the gBRCAm cohort (hazard ratio, 0.85; 95% CI, 0.61–1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCAm cohort (hazard ratio, 1.06; 95% CI, 0.81–1.37). OS by HRD status is shown in the table 1. No new safety signals were detected. Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) was reported in 14/367 patients (3.8%; 10 [7.4%] gBRCAm, 4 [1.7%] non-gBRCAm) who received niraparib versus 3/179 (1.7%; 2 [3.1%] gBRCAm, 1 [0.9%] non-gBRCAm) placebo patients. There was no evidence suggesting that toxicity, including hematologic events, MDS/AML, or cardiovascular events, contributed to the OS results.
Conclusion After reducing missing data, we provide an updated, exploratory, analysis of NOVA long-term follow-up data. NOVA was not powered to show an OS difference between arms, although the OS hazard ratio numerically favored niraparib in the gBRCAm cohort. No new safety signals were observed with long-term follow-up.
Disclosures This study was sponsored by GSK, Waltham, MA, USA.
Writing and editorial support, under the direction of the authors, was funded by GSK (Waltham, MA, USA); coordinated by Prudence Roaf, MPH, and Hasan Jamal, MSc, of GSK; and were provided by Betsy C. Taylor, PhD, CMPP, and Dena McWain of Ashfield MedComms, an Inizio company.
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