Phase 3 ARIEL3 Study: Maintenance Treatment with Rucaparib for Recurrent Ovarian Cancer and Timing of Adverse Events

2020 Year in Review - Ovarian Cancer

An analysis of phase 3 data from ARIEL3 was reviewed, providing insight into treatment-emergent adverse events (AEs) in patients receiving maintenance therapy with rucaparib for ovarian cancer.

During the virtual poster session at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, Andrew Dean, MD, Emergency Physician, Oncology, St. John of God Subiaco Hospital, Subiaco, Western Australia, Australia, reviewed data from the phase 3 clinical trial ARIEL3, and discussed the timing of treatment-emergent AEs in patients receiving maintenance treatment with rucaparib as treatment for recurrent ovarian cancer.

In the phase 3 ARIEL3 study, it had been shown previously that maintenance therapy with rucaparib significantly improves progression-free survival when compared with placebo, regardless of biomarker status in patients with recurrent ovarian cancer (NCT01968213).1 This latest analysis presented at the ESMO Virtual Congress 2020 focused on treatment-emergent AEs with an additional follow-up of 2 years for patients continuing treatment in ARIEL3, building upon data presented by Jonathan A. Ledermann, BSc, MD, FRCP, Director, Cancer Research UK and University College London Clinical Trials Centre, England, and published in Lancet Oncology, which demonstrate that maintenance therapy with rucaparib confirmed a clinically meaningful delay in starting subsequent therapy and provided lasting clinical benefits when compared with placebo.2

An assessment of the onset of treatment-emergent AEs timing was conducted. Randomization 2:1 to receive oral rucaparib (600 mg twice daily) or placebo until toxicity was deemed unacceptable, disease progression, or other reason for treatment discontinuation. The authors also analyzed the prevalence of important treatment-emergent AEs over time in addition to the time to and duration of treatment-emergent AEs first occurring.

A total of 561 patients (372 for rucaparib and 189 for placebo) were included in the safety population of the 564 patients randomized in the ARIEL3 study. The median duration of treatment was 5.5 months for the placebo arm and 8.3 months for the rucaparib arm. Excluding disease progression caused by AEs, treatment discontinuation occurred in approximately 15.3% of patients receiving rucaparib and 1.6% of patients receiving placebo. Median time to first onset for most of the frequently reported nonhematologic treatment-emergent AEs was within 1 month of therapy in the rucaparib group. The overall safety profile of rucaparib maintenance treatment in patients with recurrent ovarian cancer from ARIEL3 continues to be consistent with previous reports, identifying no new safety signals. Over the 24-month evaluation period, the prevalence of any-grade nausea declined progressively, and the prevalence of any-grade anemia and reduced hemoglobin peaked at month 4, decreasing to a level stage after 8 months. The first onset of treatment-emergent AEs primarily occurred within 45 days of treatment, while the median duration of the first event of frequently reported treatment-emergent AEs was generally within 60 days.

Source: Dean A, et al. Ann Oncol. 2020;31(4_suppl). Abstract 821P.

1. Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390:1949-1961.
2. Ledermann JA, Oza AM, Lorusso D, et al. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020;21:P710-P722.

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