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  • #512 Real-World utilisation and clinical outcomes of patients with BRCA-mutated advanced ovarian cancer treated with olaparib in the first-line maintenance setting: 2-year clinical outcomes of the pan-European OVAL-1 study

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Late Breaking Abstracts
06. Ovarian cancer
#512 Real-World utilisation and clinical outcomes of patients with BRCA-mutated advanced ovarian cancer treated with olaparib in the first-line maintenance setting: 2-year clinical outcomes of the pan-European OVAL-1 study
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  1. Domenica Lorusso1,
  2. Delphine Garbay2,
  3. Bernard Jean Roger Asselain3,
  4. Rowan Miller4,5,
  5. Francesco Raspagliesi6,
  6. Claudio Zamagni7,
  7. Alexandra Leary8,
  8. Charlotte Bellier9,
  9. Ros Glasspool10,
  10. Gordon Jayson11,
  11. Emmanuelle Grevat12,
  12. Mehdi Kertous12,
  13. Ilaria Sabatucci13,
  14. Claudia Padrone13,
  15. Parveen Jayia14,
  16. Manila Hada15,
  17. Kimmie Mclaurin15 and
  18. Charlie Gourley16
  1. 1Dipartimento Scienze della Salute della Donna, del Bambino e di Sanita’ Pubblica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS and Catholic University of the Sacred Heart, Rome, Italy
  2. 2Clinique Tivoli Ducos, Bordeaux, France
  3. 3ARCAGY-GINECO, Paris, France
  4. 4University College London Hospital, London, UK
  5. 5St Bartholomew’s Hospital, London, UK
  6. 6Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
  7. 7IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
  8. 8Institut Gustave-Roussy, Villejuif, France
  9. 9Départements De Cancérologie Gynécologique Et Sénologique, Centre Oscar Lambret, Lille, France
  10. 10Beatson West of Scotland Cancer Centre and Institute of Cancer Sciences, University of Glasgow, Glasgow, UK
  11. 11Department of Medical Oncology, The Christie NHS Foundation Trust and Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
  12. 12AstraZeneca, Paris, France
  13. 13AstraZeneca, Milan, Italy
  14. 14AstraZeneca, London, UK
  15. 15Oncology Outcomes Research, Global Medical Affairs, Evidence Generation and External Alliances, AstraZeneca, Gaithersburg, USA
  16. 16Cancer Research UK Scotland Centre, University of Edinburgh, Edinburgh, UK

Abstract

Introduction/Background In the Phase III SOLO1 trial (NCT01844986), maintenance olaparib extended progression-free survival (PFS) versus placebo (2-year PFS rates: 74% for olaparib versus 35% for placebo) in patients with BRCA-mutated (BRCAm) advanced ovarian cancer (AOC). The pan-European OVAL-1 study (NCT04532645) aims to generate the first real-world evidence with 2 years’ minimum follow-up on treatment patterns and clinical outcomes of patients with BRCAm AOC receiving olaparib in the first-line maintenance setting.

Methodology This non-interventional, retrospective, observational cohort study enrolled patients across Italy, the UK, and France who had tumour/germline BRCAm AOC, were in response following first-line platinum-based chemotherapy, and had received maintenance olaparib (300 mg twice daily; starting dose between January 2019 and June 2020). Clinical data were analysed by country. Time to real-world overall survival (rw-OS), time to treatment discontinuation (rw-TTD), time to first subsequent treatment (rw-TFST), and olaparib treatment patterns were evaluated.

Results Of 357 patients enrolled, 342 were eligible for analysis. Country-specific patient characteristics, rw-OS, rw-TTD, rw-TFST, and adverse events (AEs) are presented in the table 1. The UK had a higher proportion of International Federation of Gynaecology and Obstetrics (FIGO) stage IV patients, lower rw-OS and lower rw-TFST compared with Italy and France. AEs were reported in 79.0%, 60.9%, and 40.8% of patients from Italy, the UK, and France, respectively. Anaemia and nausea were the most common AEs. One case of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) was reported in France.

View this table:
Abstract #512 Table 1

2-year interim patient demographics; olaparib treatment patterns; rw-TTD, rw-OS; rw-TFST, and AEs in the OVAL-1 trial

Conclusion 2-year interim data from the pan-European OVAL-1 study demonstrate the real-world effectiveness and safety of first-line maintenance olaparib, complementing findings from the randomised controlled SOLO1 trial in patients with AOC. Future analyses will include longer follow-up treatment patterns, safety, and effectiveness, and pooled analyses from the participating countries.

Disclosures This study was funded by AstraZeneca and is part of an alliance between AstraZeneca and Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

https://doi.org/10.1136/ijgc-2023-ESGO.895

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