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O016/#233 Clinical and molecular characteristics of ariel3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian cancer (HGOC)
  1. RL Coleman1,2,
  2. A Oza3,
  3. D Lorusso4,5,
  4. C Aghajanian6,
  5. A Oaknin7,
  6. A Dean8,
  7. N Colombo9,
  8. J Weberpals10,
  9. A Clamp11,
  10. G Scambia5,
  11. A Leary12,
  12. R Holloway13,
  13. M Amenedo Gancedo14,
  14. P Fong15,
  15. J Goh16,
  16. D O’Malley17,
  17. L Maloney18,
  18. S Goble19,
  19. T Kwan20 and
  20. J Ledermann21
  1. 1University of Texas MD anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, Houston, USA
  2. 2US Oncology Research, Research, The Woodlands, USA
  3. 3Princess Margaret Cancer Centre, University Health Network, Division of Medical Oncology and Hematology, Toronto, Canada
  4. 4Fondazione IRCCS, Istituto Nazionale dei Tumori, Multicenter Italian Trials In Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Milan, Italy
  5. 5Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Gynecologic Oncology Unit, Rome, Italy
  6. 6Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, USA
  7. 7Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Gynecologic Cancer Program, Barcelona, Spain
  8. 8St John of God Subiaco Hospital, Department of Oncology, Subiaco, Australia
  9. 9University of Milan-Bicocca and European Institute of Oncology (IEO) IRCCS, Gynecologic Cancer Program, Milan, Italy
  10. 10Ottawa Hospital Research Institute, Division of Gynecologic Oncology, Ottawa, Canada
  11. 11The Christie NHS Foundation Trust and University of Manchester, Department of Medical Oncology, Manchester, UK
  12. 12Gustave Roussy Cancer Center, INSERM U981, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Gynecological Unit, Villejuif, France
  13. 13Florida Hospital Cancer Institute, Department of Gynecologic Oncology, Orlando, USA
  14. 14Oncology Center of Galicia, Medical Oncology Department, La Coruña, Spain
  15. 15Auckland City Hospital and University of Auckland, Medical Oncology Department, Auckland, New Zealand
  16. 16Royal Brisbane and Women’s Hospital, Herston, and University of Queensland, Department of Oncology, Cancer Care Services, St Lucia, Australia
  17. 17The Ohio State University, James Cancer Center, Division of Gynecologic Oncology, Columbus, USA
  18. 18Clovis Oncology, Inc., Clinical Development, Boulder, USA
  19. 19Clovis Oncology, Inc., Biostatistics, Boulder, USA
  20. 20Clovis Oncology, Inc., Molecular Diagnostics and Translational Medicine, Boulder, USA
  21. 21UCL Cancer Institute, University College London and UCL Hospitals, Department of Oncology, London, UK


Objectives ARIEL3 is a placebo-controlled randomized trial of the PARP inhibitor (PARPi) rucaparib as maintenance treatment in HGOC patients who responded to the latest line of platinum therapy (NCT01968213). Rucaparib improved progression-free survival (PFS) across all predefined subgroups. Here, we present an exploratory analysis of characteristics associated with exceptional benefit from rucaparib.

Methods Patients were randomized 2:1 to rucaparib 600 mg BID or placebo. As of 31 Dec 2019 (data cutoff), 33/375 (9%) and 1/189 (0.5%) patients were still ongoing and receiving rucaparib or placebo. Molecular features (genomic alterations, BRCA1 promoter methylation) and baseline clinical characteristics were compared between patients who derived exceptional benefit (PFS ≥2 yrs), and those with disease progression on first scan (≈12 wks; the short-term subgroup) within each treatment arm.

Results of 564 patients, 79/375 (21%) in the rucaparib arm and 4/189 (2%) in the placebo arm showed exceptional benefit. Within the rucaparib arm, exceptional benefit patients had more favorable clinical prognostic factors at baseline versus the short-term subgroup (Table). Although BRCA mutations were enriched in the rucaparib exceptional benefit subgroup, 33/79 (42%) of these patients were BRCA wild type. Patterns of enrichment varied among other biomarkers. Overall trends were similar in the placebo arm.

Conclusions Exceptional benefit in ARIEL3 was more common in, but not exclusive to, patients with favorable clinical characteristics and known mechanisms of PARPi sensitivity. Our results suggest rucaparib can deliver exceptional benefit to a diverse set of patients with HGOC.

Abstract O016/#233 Table 1

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