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2022-RA-249-ESGO Overall survival results from ariel3: a phase 3 randomised, double-blind study of rucaparib vs placebo following response to platinum-based chemotherapy for recurrent ovarian carcinoma
  1. Robert L Coleman1,2,
  2. Amit M Oza3,
  3. Domenica Lorusso4,
  4. Carol Aghajanian5,
  5. Ana Oaknin6,
  6. Andrew Dean7,
  7. Nicoletta Colombo8,
  8. Johanne I Weberpals9,
  9. Andrew R Clamp10,
  10. Giovanni Scambia11,
  11. Alexandra Leary12,
  12. Robert W Holloway13,
  13. Margarita Amenedo Gancedo14,
  14. Peter C Fong15,
  15. Jeffrey C Goh16,
  16. David M O’Malley17,
  17. Sandra Goble18,
  18. Lara Maloney19 and
  19. Jonathan A Ledermann20
  1. 1Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
  2. 2*current location: US Oncology Research, The Woodlands, TX
  3. 3Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada
  4. 4MITO and Gynecologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  5. 5Gynecologic Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY
  6. 6Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain
  7. 7Department of Oncology, St John of God Subiaco Hospital, Subiaco, WA, Australia
  8. 8Gynecologic Cancer Program, European Institute of Oncology and University of Milan-Bicocca, Milan, Italy
  9. 9Division of Gynecologic Oncology, Ottawa Hospital Research Institute, Ottawa, ON, Canada
  10. 10Department of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK
  11. 11Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Rome, Italy
  12. 12Gynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Villejuif, France
  13. 13Department of Gynecologic Oncology, Florida Hospital Cancer Institute, Orlando, FL
  14. 14Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain
  15. 15Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand
  16. 16Department of Oncology, Cancer Care Services, Royal Brisbane and Women’s Hospital, Herston, QLD, Australia, and University of Queensland, St Lucia, QLD, Australia
  17. 17Clinical Research Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH
  18. 18Biostatistics, Clovis Oncology, Inc., Boulder, CO
  19. 19Clinical Development, Clovis Oncology, Inc., Boulder, CO
  20. 20Department of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, London, UK


Introduction/Background In ARIEL3 (NCT01968213), progression-free survival (PFS) improved significantly with rucaparib maintenance treatment versus placebo. We present updated PFS2 and preplanned final overall survival (OS) analyses.

Methodology ARIEL3 enrolled patients with platinum-sensitive, high-grade ovarian carcinoma who had received ≥2 previous platinum-based chemotherapy regimens and had responded to their last platinum-based regimen. Patients were randomised 2:1 to receive rucaparib 600 mg twice daily or placebo, with 3 protocol-defined nested cohorts: BRCA-mutant, homologous recombination deficient (HRD) and intent-to-treat (ITT). Efficacy outcomes for the nested cohorts included the secondary endpoint of OS (with analysis planned after 70% of events) and the exploratory endpoint of PFS2 (defined as time from randomisation to second event of investigator-assessed disease progression or death due to any cause). Patients were followed for the incidence of myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). Data cutoff dates were 31 December 2019 (safety), 4 April 2022 (efficacy) and 12 April 2022 (monitoring of MDS/AML).

Results After a median follow-up of 77.0 months in the ITT population, 410/564 (72.7%) of OS events had occurred. OS and PFS2 are presented in table 1. A PARP inhibitor was administered as subsequent treatment to ≈45% of patients who received placebo. Safety data were consistent with those of prior reports. MDS/AML was reported in 14 (3.8%) and 6 (3.2%) patients in the rucaparib and placebo arms, respectively (P=0.72). Among these, 8 patients in the rucaparib arm and 6 in the placebo arm developed MDS/AML after completion of study drug treatment.

Abstract 2022-RA-249-ESGO Table 1

Conclusion These data support the use of rucaparib as a maintenance treatment for recurrent ovarian carcinoma. Although no OS benefit was observed, the PFS benefit for rucaparib was maintained through the next subsequent line of therapy.

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