Ledermann, Jonathan A;
Oza, Amit M;
Lorusso, Domenica;
Aghajanian, Carol;
Oaknin, Ana;
Dean, Andrew;
Colombo, Nicoletta;
... Coleman, Robert L; + view all
(2025)
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
, 225
, Article 115584. 10.1016/j.ejca.2025.115584.
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1-s2.0-S0959804925003661-main.pdf - Accepted Version Access restricted to UCL open access staff until 28 June 2026. Download (1MB) |
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.
| Type: | Article |
|---|---|
| Title: | Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: final results of the phase 3, randomized, placebo-controlled ARIEL3 trial |
| DOI: | 10.1016/j.ejca.2025.115584 |
| Publisher version: | https://doi.org/10.1016/j.ejca.2025.115584 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions. |
| Keywords: | BRCA, Homologous recombination deficient, Long-term follow-up, Recurrent ovarian cancer, Overall survival, PFS2, Progression-free interval, Poly(ADP-ribose) polymerase inhibitor |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10210481 |
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