Introduction/Background In this preliminary evaluation of the first 324 patients enrolled in the OVAL-1 study (NCT04532645), we report real-world characteristics and first-year therapy management among tumour or germline (t/g) BRCA1/BRCA2-mutated (t/gBRCAm) newly diagnosed advanced ovarian cancer (OC) patients who received maintenance olaparib across Italy, UK and France.

Methodology This observational, retrospective study included patients who received maintenance olaparib (300 mg bid) for t/gBRCAm advanced OC following response to first-line platinum-based chemotherapy. Eligible patients received their first dose between January 2019 and June 2020 (index date). The planned enrolment is 350 patients. Data are collected from routine clinical practice. Adverse events (AEs) were defined as any untoward medical occurrence in a patient; AE data were only collected if AEs resulted in dose reduction or treatment interruption or discontinuation. This analysis reports data by country with a planned pooled analysis at the third year of follow-up. Included are patients followed between index date and first data extraction (France) or with a minimum follow-up of 1 year (Italy and UK).

Results By the end of January 2022, Italy (n=125) and UK (n=116) had completed enrolment; data were available from the first 83 patients from France. Baseline patient characteristics are shown in table 1. Most patients had a diagnosis of FIGO stage III disease. Anaemia, nausea, fatigue, and neutropenia were the most frequently reported AEs across the countries (table 2). Progression-free survival endpoint data are not yet mature.

Conclusion These preliminary descriptive analyses provide insights into real-world management of newly diagnosed advanced OC in Italy, UK, and France. Safety was consistent with previous reports of maintenance olaparib in this setting. Future analyses will focus on survival endpoints and country-specific analyses.