Abstract 52P
Background
Niraparib (PARP inhibitor) is approved in advanced ovarian cancer (OC) as maintenance therapy in the first line and recurrent platinum-sensitive settings. The MONITOR-UK study was designed to report real-world niraparib experience in UK clinical practice.
Methods
In this national, multi-centre, observational study (NCT04295577), patients with newly diagnosed or recurrent OC treated with maintenance niraparib were enrolled. The primary endpoint is the incidence of grade ≥3 treatment emergent adverse events (TEAEs). Secondary endpoints include PFS and quality of life. Recruitment is ongoing (n=375 planned). We report an initial, descriptive analysis of subjects enrolled with at least 6 months (mo) follow up.
Results
Between 12/2019 and 8/2023, 319 eligible patients were enrolled from 14 centres; median age 68 years (IQR 59-74); 166/319 (52%) first line (139/166 (84%) prospective); 153/319 (48%) recurrent OC (110/153 (72%) prospective); 300mg initial dose 24%. Median follow-up 17.3 mo (IQR 8.7 - 27.8). Among first line patients, 111/166 (67%) stage III at initial diagnosis; 59/166 (36%) neoadjuvant chemotherapy; 126/166 (76%) cytoreductive surgery; 103/126 (82%) no residual disease. 106 (33%) patients experienced a grade ≥3 TEAE: hypertension (n=44, 14%), anaemia (n=27, 8%), low neutrophil (n=20, 6%) and low platelet count (n=20, 6%). Adverse events of special interest included secondary cancer diagnosis (n=6), pneumonitis (n=2), AML (n=1) and MDS (n=1). Discontinuation rate due to TEAEs was 5%. 47% patients had dose reductions. In the first line, median PFS for all-comers was 12.5 mo (95% CI, 9.7 - 15.8); median PFS for stage III without residual disease 14.6 mo (95% CI, 11.3 - 17.3) and 8.5 mo (95% CI, 5.6 - 10.8) for stage III with residual disease. In patients with recurrent disease, the PFS was 15.4 (95% CI, 8.5 - 40.9) and 7.1 (95% CI, 5.4 - 8.5) mo in BRCA-mutated (n=17, 11%) and all-comers, respectively.
Conclusions
In this real-world, ongoing, observational study, which included first line patients without residual disease, the occurrence of treatment-related adverse events graded ≥3 reported is lower than reported in phase III clinical trials. Clinical outcomes and biomarker status will be updated.
Clinical trial identification
NCT04295577.
Legal entity responsible for the study
The authors.
Funding
Academic-sponsored study, funding from GSK.
Disclosure
R. Bowen: Financial Interests, Personal, Advisory Role, Consulting fees: GSK, AstraZeneca, Clovis; Financial Interests, Personal, Speaker’s Bureau, Lectures/ presentations: AstraZeneca, GSK, Eisai. J. McGrane: Financial Interests, Personal, Other, Travel honoraria: Astellas, Bristol Myers Squibb, GSK (Tesaro), Ipsen; Financial Interests, Personal, Invited Speaker, Speaking Honoraria: Astellas, Bayer, Bristol Myers Squibb, Eisai, GSK, Janssen-Cilag, Ipsen, Pfizer, Merck, MSD, Roche; Financial Interests, Personal, Advisory Role, Consultancy / Advisory: Astellas, Bristol Myers Squibb, Eisai, Ferring, GSK (Tesaro), Ipsen, Pfizer, Merck, MSD, Roche; Financial Interests, Personal, Other, Director: MySunrise Cancer Support App. A. Walther: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal, Other, Educational activities: GSK. R. Miller: Financial Interests, Personal, Advisory Board, Consultancy: MSD, GSK, AstraZeneca, Ellipses, Shionogi, Clovis Oncology, Immunogen and GI Innovation; Financial Interests, Personal, Speaker’s Bureau: GSK, AstraZeneca and Clovis Oncology; Financial Interests, Institutional, Research Grant, Trial Funding: MSD and GSK; Financial Interests, Personal, Other, Travel grants: AstraZeneca, MSD and GSK. S. Williams: Financial Interests, Personal, Advisory Role, Meeting sponsorship and consultation fees: MSD. S. Banerjee: Financial Interests, Personal, Advisory Board: Immunogen, Mersana, MSD, Roche, AstraZeneca, GSK, Oncxerna, Shattuck Labs, Novartis, Epsilogen, Seagen, Eisai, Regeneron, Verastem, Myriad; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, Takeda, Amgen, Medscape, Research to Practice, Peerview, Novacure; Financial Interests, Personal, Stocks/Shares: PerciHealth; Financial Interests, Institutional, Research Grant: AstraZeneca, GSK; Non-Financial Interests, Personal, Principal Investigator, Phase II clinical trial Global lead, ENGOTov60/GOG3052/RAMP201: Verastem; Non-Financial Interests, Personal, Principal Investigator, ENGOT-GYN1/ATARI phase II international trial (academic sponsored): AstraZeneca; Non-Financial Interests, Personal, Principal Investigator, Academic sponsored trial PI (MONITOR-UK): GSK; Non-Financial Interests, Personal, Advisory Role, Medical advisor to UK ovarian cancer charity: Ovacome Charity; Non-Financial Interests, Personal, Leadership Role, Board Member: International Cancer Foundation (ICF). All other authors have declared no conflicts of interest.