Dr Kristeleit on the Implications of Long-Term Data With Rucaparib in Advanced Ovarian Cancer

Rebecca Kristeleit, BSc, MBChB, MRCP, PhD, consultant medical oncologist, clinical senior lecturer, Department of Oncology, University College-London Cancer Institute, discusses the phase 3 ATHENA-MONO trial (NCT03522246) in newly diagnosed patients with advanced ovarian cancer, highlighting the clinical implications of these long-term findings.

During the 2024 SGO Annual Meeting, investigators unveiled a comprehensive follow-up analysis examining key end points, such as time to first subsequent treatment (TFST), second disease progression or death (PFS2), and overall survival. The primary motivation behind conducting this ad-hoc analysis was to furnish essential data in support of an application submitted to the European Medicines Agency seeking the European approval for the use of rucaparib (Rubraca) in the first-line ovarian cancer setting, a milestone that has since been successfully achieved, Kristeleit begins.

As the findings continue to evolve and mature, Kristeleit says she and investigators anticipate the release of additional long-term data. The cutoff date for the data stands at March 9, 2023, indicating that further insights into the long-term efficacy of rucaparib will be forthcoming in the near future, Kristeleit notes. Kristeleit goes on to share that her optimism rests on the belief that these data will not only fortify existing rucaparib approvals but also pave the way for potential approvals of this agent within the United States.

The long-term outcomes delineated in the ATHENA-MONO study serve to underscore the efficacy of rucaparib in the first-line maintenance setting as an adjunctive therapy, independent of molecular status, and characterized by a notably manageable toxicity profile, she continues. This development heralds positive implications for women grappling with ovarian cancer, Kristeleit adds. Apart from yielding a progression-free survival advantage over placebo, rucaparib maintenance therapy has demonstrated efficacy in prolonging both TFST and PFS2 in patients newly diagnosed with ovarian cancer, irrespective of homologous recombination deficiency or BRCA mutation status, she concludes.