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3 Postprogression efficacy outcomes from the phase 3 ARIEL3 study of rucaparib in patients with platinum-sensitive recurrent ovarian carcinoma associated with either BRCA1 or BRCA2 mutations
  1. J Weberpals1,
  2. A Oza2,
  3. D Lorusso3,
  4. G Scambia3,
  5. C Aghajanian4,
  6. A Oaknin5,
  7. A Dean6,
  8. N Colombo7,
  9. AR Clamp8,
  10. A Leary9,
  11. RW Holloway10,
  12. M Amenedo Gancedo11,
  13. PC Fong12,
  14. JC Goh13,
  15. DM O’Malley14,
  16. DK Armstrong15,
  17. S Banerjee16,
  18. J García-Donas17,
  19. EM Swisher18,
  20. T Cameron19,
  21. L Maloney20,
  22. S Goble20,
  23. RL Coleman21 and
  24. JA Ledermann22
  1. 1Ottawa Hospital Research Institute, Canada
  2. 2Princess Margaret Cancer Centre, University Health Network, Canada
  3. 3Fondazione Policlinico Universitario A. Gemelli IRCCS, Italy
  4. 4Memorial Sloan Kettering Cancer Center, USA
  5. 5Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Spain
  6. 6St John of God Subiaco Hospital, Australia
  7. 7European Institute of Oncology IRCCS and University of Milan-Bicocca, Italy
  8. 8The Christie NHS Foundation Trust and University of Manchester, UK
  9. 9Gustave Roussy Cancer Center, INSERM U981, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), France
  10. 10AdventHealth Cancer Institute Orlando, USA
  11. 11Oncology Center of Galicia, Spain
  12. 12Auckland City Hospital and University of Auckland, New Zealand
  13. 13Royal Brisbane and Women’s Hospital, Herston and University of Queensland, Australia
  14. 14The Ohio State University, James Cancer Center, USA
  15. 15Johns Hopkins University School of Medicine, USA
  16. 16The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, UK
  17. 17HM Hospitales—Centro Integral Oncológico Hospital de Madrid Clara Campal, Spain
  18. 18University of Washington, USA
  19. 19Clovis Oncology UK Ltd., UK
  20. 20Clovis Oncology, Inc., USA
  21. 21US Oncology Research, USA
  22. 22UCL Cancer Institute, University College London and UCL Hospitals, UK


Introduction In ARIEL3 (NCT01968213), rucaparib maintenance for recurrent ovarian cancer (rOC) significantly improved investigator-assessed PFS and postprogression efficacy outcomes versus placebo regardless of biomarker status. PFS was also improved in patients with rOC associated with either BRCA1 or BRCA2 mutations (HR, 0.32 [95% CI, 0.19–0.53] and 0.12 [0.06–0.26], respectively). This exploratory analysis further examined the subgroup of patients with rOC associated with BRCA1 or BRCA2 mutations to assess the durability of the clinical benefit of rucaparib maintenance following disease progression.

Methods Patients were randomised 2:1 to oral rucaparib (600 mg twice daily) or placebo. Postprogression efficacy endpoints were assessed in patients with germline or somatic BRCA1 or BRCA2 mutations.

Results Investigator-assessed postprogression efficacy endpoints for patients with either BRCA1 or BRCA2 mutations are presented in the table 1.

There was a trend for better outcomes across all endpoints in patients with BRCA1 and BRCA2 mutations, with larger differences between the median values among patients with a BRCA2 mutation. The treatment-by-mutation group interaction test reached statistical significance for TFST and CFI.

Among rucaparib-treated patients, the most common treatment-emergent adverse events (any grade) in the BRCA1 and BRCA2 subgroups were nausea (81.0% and 78.0%) and asthenia/fatigue (74.7% and 80.0%).

Abstract 3 Table 1

Conclusions/Implications All postprogression efficacy endpoints were longer with rucaparib maintenance than with placebo in both BRCA-mutant subgroups. Safety data for the two subgroups were similar and were consistent with the overall safety population.

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