Abstract 59P
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. It is reimbursed in France since May 2019.
Methods
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 second-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. 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%), between 4-8 weeks after PBCT (57%) and in 2L (62%). Median exposure to niraparib was of 97 days and 76% of patients discontinued niraparib during the observational period. Among the 295 pts who discontinued niraparib, 56% discontinued for progression and 32% for toxicity. Median progression-free survival (mPFS) was estimated at 7.2 [95% CI 6.2-8.5] months (mo) in the main population. Unadjusted analyses in the NOVA like population showed comparable efficacy regardless the timing of initiation: median PFS of 8.7 [6.4-13.0] mo after 8 weeks (w) vs mPFS of 6.8 [6.0-8.5] mo before 8 w; as well as regardless of the dose, mPFS 8.7 [6.7–12.0] mo for patients who initiated niraparib at 300 mg vs mPFS of 6.8 [6.2-8.2] m for those who initiated niraparib at a lower dose. However, mPFS was higher for pts who initiated niraparib in 2L (8.7 [7.3-9.8] mo) compared to 3L+ (5.2 [4.0-6.2]).
Conclusions
First study providing real-word data on the use of niraparib in French OC patients shows efficacy results (PFS) consistent with the randomized NOVA trial results. Niraparib can be introduced more than 8 w after end of PBCT without loss of efficacy; as well as initiated at the recommended dose depending on the pts features. The main reason for niraparib discontinuation was progression.
Clinical trial identification
NCT03275298.
Legal entity responsible for the study
Unicancer manages independently ESME OC database (i.e., data collection, analyses and publication) and is the sole data controller for data processing. GSK was provided the opportunity to provide a courtesy review of the preliminary version of this publication for accuracy only, but the authors are solely responsible for final content and interpretation.
Funding
The ESME Ovarian Cancer database (NCT03275298) received financial support from industrial partners. Unicancer manages the database (i.e., data collection, analyses and publication) independently. Funding for this study was provided by GSK (study ID 214491).
Disclosure
L. Gladieff: Financial Interests, Personal, Other, Congress funding: Viatris, Roche; Financial Interests, Institutional, Invited Speaker: MSD, Clovis, GSK, Eisai; Financial Interests, Institutional, Advisory Board: Clovis, GSK; Financial Interests, Personal, Invited Speaker: AstraZeneca. C. Lachaize: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb, GSK. F. Joly Lobbedez: Financial Interests, Personal, Advisory Board: GSK, AstraZeneca, MSD, Janssen, Ipsen, Bayer, Astellas, Eisai, Seagen, Novocure, Pfizer; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, MSD, Janssen, Ipsen, Amgen, Novartis/3A, Eisai, Amgen, Eisai; Financial Interests, Institutional, Invited Speaker: Viatris, GSK, AstraZeneca; Financial Interests, Institutional, Research Grant: BMS, Astellas; Financial Interests, Institutional, Funding: Janssen; Non-Financial Interests, Personal, Member: GCIG; Other, Personal, Other, travel and congress: MSD, Ipsen, Chugai; Other, Personal, Other, travel: GSK, Eisai. A. Fages: Financial Interests, Personal, Full or part-time Employment: GSK. G.J. Nachbaur: Financial Interests, Personal, Full or part-time Employment: GSK; Financial Interests, Personal, Stocks/Shares: GSK. C. Pomel: Financial Interests, Personal, Advisory Board: Roche, GSK, PharmaMar, MSD; Financial Interests, Personal, Invited Speaker: Roche, GSK, PharmaMar; Financial Interests, Personal, Expert Testimony: Roche. P. Colombo: Financial Interests, Personal, Invited Speaker: GSK, MSD. L. Bosquet: Financial Interests, Institutional, Full or part-time Employment, In charge of scientific projects at Unicancer, Health Data and Partnership Department: Unicancer. I.L. Ray-Coquard: Financial Interests, Personal, Advisory Board: Roche, GSK, AstraZeneca, Mersana, Deciphera, Amgen, Oxnea, Merck Sereno, Agenus, Novartis, Macrogenics, Clovis, EQRX, Adaptimmune, Eisai, Sutro, BMS, Adaptimmune, Daiichi Sankyo, Immunogen, Seagen, PMVpharma; Financial Interests, Institutional, Other, Colibri translational research: BMS; Financial Interests, Institutional, Advisory Board, translational research NEOPREMBROV trial: MSD; Non-Financial Interests, Personal, Principal Investigator: PAOLA1; Non-Financial Interests, Personal, Other, President: GINECO. M.J. Rodrigues: Financial Interests, Personal, Invited Speaker: Immunocore; Financial Interests, Personal, Advisory Board: GSK, AstraZeneca; Financial Interests, Institutional, Invited Speaker: Johnson & Johnson; Non-Financial Interests, Institutional, Product Samples: MSD. All other authors have declared no conflicts of interest.