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Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial

Ledermann, J. A.
; 
Oza, A. M.
; 
Lorusso, D.
; 
Aghajanian, C.
; 
Oaknin, A.
; 
Dean, A.
; 
Colombo, N.
; 
Weberpals, J. I.
; 
Clamp, A. R.
; 
Scambia, G.
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Abstract
BACKGROUND: In ARIEL3, rucaparib maintenance significantly improved progression-free survival (PFS; primary endpoint) and long-term follow-up (LTFU) outcomes (including PFS2: time to disease progression on subsequent therapy or death) versus placebo in patients with recurrent, platinum-sensitive ovarian cancer. Here we report the final analysis of overall survival (OS; key secondary endpoint), LTFU outcomes, and safety. METHODS: OS and updated LTFU efficacy outcomes were analyzed (data cutoff date: April 4, 2022) across three nested populations (BRCA-mutated, homologous recombination deficient [HRD], and intention to treat [ITT]). RESULTS: Patients were randomized 2:1 to rucaparib (600 mg BID; n = 375) or placebo (n = 189). Median follow-up was 77.0 months. 168 patients in the placebo arm received subsequent treatment; of these, 77 (46 %) received a poly(ADP-ribose) polymerase inhibitor-containing treatment. Median OS from randomization post chemotherapy for rucaparib vs placebo was 45.9 vs 47.8 months (HR 0.83, 95 % CI 0.58-1.19) for the BRCA-mutated population; no OS benefit was found with rucaparib in the HRD and ITT populations. Median PFS2 for rucaparib vs placebo was 26.1 vs 18.4 months (HR 0.67, 95 % CI 0.48-0.94) for the BRCA-mutated population. Rucaparib numerically improved PFS2 and other LTFU outcomes versus placebo in the HRD and ITT populations. Safety was consistent with prior reports; myelodysplastic syndrome and/or acute myeloid leukemia occurred in 4 % and 3 % of patients in the rucaparib and placebo arms, respectively. CONCLUSIONS: OS was similar between treatment arms. PFS benefit with rucaparib was maintained through the subsequent therapy line. These data support rucaparib as maintenance treatment for recurrent ovarian carcinoma.
Authors
Ledermann, J. A.
Oza, A. M.
Lorusso, D.
Aghajanian, C.
Oaknin, A.
Dean, A.
Colombo, N.
Weberpals, J. I.
Clamp, A. R.
Scambia, G.
Leary, A.
Holloway, R. W.
Gancedo, M. A.
Fong, P. C.
Goh, J. C.
O'Malley, D. M.
Armstrong, D. K.
Banerjee, S.
García-Donas, J.
Swisher, E. M.
Lebreton, C.
Konecny, G. E.
McNeish, I. A.
Scott, C. L.
Maloney, L.
Goble, S.
Lin, K. K.
Coleman, R. L.
Affiliation
UCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk. Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. MITO and Gynecologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Memorial Sloan Kettering Cancer Center, New York, NY, USA. Medical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain. St John of God Subiaco Hospital, Subiaco, Western Australia, Australia. Gynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy. Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. The Christie NHS Foundation Trust and University of Manchester, Manchester, UK. Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore and Scientific Directorate, Rome, Italy. Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France. AdventHealth Cancer Institute, Orlando, FL, USA. Oncology Center of Galicia, La Coruña, Spain. Auckland City Hospital and the University of Auckland, Grafton, Auckland, New Zealand. Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Queensland University of Technology, Brisbane, Queensland, Australia. The Ohio State University, James Cancer Center Hospital, Columbus, OH, USA. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA. The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK. Centro Integral Oncológico Clara Campal, Madrid, Spain. University of Washington, Seattle, WA, USA. Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France. University of California, Los Angeles, Los Angeles, CA, USA. Imperial College London, London, UK. Royal Melbourne Hospital, Parkville, and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia. Clovis Oncology, Inc., Boulder, CO, USA. The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
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2025
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All Christie Publications
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Ledermann JA, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, et al. Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial. European journal of cancer (Oxford, England : 1990). 2025 Jul 25;225:115584. PubMed PMID: 40580808. Epub 2025/07/01. eng.
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https://christie.openrepository.com/handle/10541/628090
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