Real-world overall survival in second-line maintenance niraparib monotherapy versus active surveillance in patients with BRCA wild-type recurrent ovarian cancer.

Background: The NOVA study (NCT01847274) compared niraparib with placebo as a maintenance treatment for patients with recurrent ovarian cancer (OC) but was not powered to detect an overall survival (OS) improvement.

Objective: To compare OS in a real-world population of patients with BRCA wild-type (BRCAwt) recurrent OC who received second-line maintenance (2LM) niraparib monotherapy versus active surveillance (AS).

Design: A retrospective study using a US-based nationwide deidentified electronic health record-derived database.

Methods: Patients diagnosed with epithelial OC (January 1, 2011-May 31, 2021) who completed second-line (2L) therapy (January 1, 2017-March 2, 2022) and were BRCAwt were included. A NOVA study-like subpopulation included patients with an Eastern Cooperative Oncology Group performance status score of 0-1 and platinum-sensitive disease. Patients were assigned to 2LM niraparib or AS cohorts. Follow-up was measured from the index date (2L non-maintenance therapy end) until the first of study end (May 31, 2022), last clinical activity, or death. Median OS (mOS) and hazard ratios were estimated with an emulated trial methodology.

Results: The overall population comprised 199 patients in the 2LM niraparib monotherapy cohort and 707 patients in the AS cohort; the NOVA study-like subpopulation included 123 patients in the 2LM niraparib monotherapy cohort and 143 in the AS cohort. Demographic and clinical characteristics were similar in both populations. Overall, adjusted mOS was 24.1 months for the 2LM niraparib monotherapy cohort versus 18.4 months for the AS cohort (hazard ratio, 0.8; 95% confidence interval [CI]: 0.7-0.9). In the NOVA study-like subpopulation, adjusted mOS was 28.1 months for the 2LM niraparib monotherapy cohort versus 21.5 months for the AS cohort (hazard ratio, 0.6; 95% CI: 0.5-0.9).

Conclusion: These results provide important real-world OS data for patients with recurrent BRCAwt OC who received niraparib monotherapy compared with patients receiving AS.