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Introduction/Background Niraparib is a PARP inhibitor first approved by EMA in 2017 as maintenance monotherapy in patients (pts) with platinum-sensitive relapsed high grade serous epithelial ovarian cancer (OC) who are in response to platinum-based chemotherapy (PBCT), based on the NOVA study. Niraparib is reimbursed in France since May 2019. Methodology This study aimed to retrospectively analyze the ESME French real-world dataset of OC pts to describe the clinical characteristics, treatment patterns and survival outcomes of pts who initiated niraparib in 2nd line or beyond (2L+) between May 2019 and Jul 2021. Subgroup analyses on pts eligible per the main criteria of the NOVA trial were explored. Results 389 pts were eligible (including 139 NOVA-like pts; 36%), with a median follow-up of 12 months. Mean age was 63 years, mean weight was 68kg. Most pts (93%) had initial FIGO stage III (68%) or IV (25%), 86% had serous histology and 93% of pts with available results were BRCAwt. Niraparib was mostly initiated in complete or partial PBCT responders (73%), at a dose of 200mg (72%) and in 2L (62%). 64% of pts received bevacizumab as prior maintenance therapy, none received a prior PARP inhibitor. Median progression-free survival (mPFS) was estimated at 7.2 months in the main population, and at 8.6 months in the NOVA-like subgroup. Subgroup analyses showed longer mPFS in earlier lines of niraparib initiation (mPFS of 8.7 months in 2L), in pts with a penultimate PBCT-free interval ≥12 months (mPFS 9.7 months) and in PBCT complete responders (mPFS 10.1 months). Conclusion Niraparib efficacy in real-life is consistent with clinical data in the 2L+ setting from NOVA. Results of this study suggest that niraparib should be started in earliest line and that its benefit in real-life seems higher in pts highly sensitive to PBCT and in PBCT complete responders. Disclosures The ESME Ovarian Cancer database received financial support from industrial partners. Unicancer manages the database (i.e. data collection, analysis and publication) independently. Author's COI have been recorded online.
Gladieff et al. (2024) studied this question.