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  • 1 Analysis of patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian cancer in the phase 3 ARIEL3 study

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Ovarian cancer
1 Analysis of patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian cancer in the phase 3 ARIEL3 study
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  1. J Ledermann1,
  2. A Oza2,
  3. D Lorusso3,
  4. C Aghajanian4,
  5. A Oaknin5,
  6. A Dean6,
  7. N Colombo7,
  8. J Weberpals8,
  9. T Kwan9 and
  10. R Coleman10
  1. 1UCL Cancer Institute, University College London and UCL Hospitals, Department of Oncology, London, UK
  2. 2Princess Margaret Cancer Centre, University Health Network, Division of Medical Oncology and Hematology, Toronto, Canada
  3. 3Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy*
  4. 4Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, USA
  5. 5Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Gynecologic Cancer Program, Barcelona, Spain
  6. 6St John of God Subiaco Hospital, Department of Oncology, Subiaco, Australia
  7. 7University of Milan-Bicocca and European Institute of Oncology (IEO) IRCCS, Gynecologic Cancer Program, Milan, Italy
  8. 8Ottawa Hospital Research Institute, Division of Gynecologic Oncology, Ottawa, Canada
  9. 9Clovis Oncology, Inc., Molecular Diagnostics and Translational Medicine, Boulder, USA
  10. 10Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA†
  11. *Affiliation where the work was conducted; current affiliation: Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Rome, Italy
  12. †Affiliation where the work was conducted; current affiliation: US Oncology Research, The Woodlands, TX, USA

Abstract

Introduction/Background*ARIEL3 is a placebo-controlled randomized trial of the PARP inhibitor rucaparib as maintenance treatment in high-grade ovarian cancer (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.

Methodology Between 7 April 2014, and 19 July 2016, 564 patients were randomized 2:1 to rucaparib 600 mg BID or placebo. As of 31 December 2019 (data cutoff), 33/375 (9%) and 1/189 (0.5%) patients were still ongoing and receiving rucaparib or placebo. Molecular features (genomic alterations and BRCA1 promoter methylation) and baseline clinical characteristics were compared between patients who derived exceptional benefit (PFS ≥2 years), and those with disease progression on first scan (≈12 weeks; the short-term subgroup) within each treatment arm.

Result(s)*Of 564 patients, a greater percentage of rucaparib vs placebo patients showed exceptional benefit: 79/375 (21%) in the rucaparib arm and 4/189 (2%) in the placebo arm (including 26/375 [7%] patients in the rucaparib arm and 1/189 [0.5%] patient in the placebo arm with PFS >4 years as of the data cutoff date). Within the rucaparib arm, exceptional benefit patients had more favourable clinical prognostic factors at baseline versus the short-term subgroup (table 1). Although BRCA (BRCA1 or BRCA2) 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.

View this table:
Abstract 1 Table 1

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

http://dx.doi.org/10.1136/ijgc-2021-ESGO.331

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