Rucaparib Active in Relapsed, Platinum-sensitive Ovarian Cancer

The FDA granted accelerated approval to rucaparib in 2016 for the single agent treatment of BRCA mutation associated advanced ovarian cancer.
The FDA granted accelerated approval to rucaparib in 2016 for the single agent treatment of BRCA mutation associated advanced ovarian cancer.

In patients with relapsed, platinum-sensitive high-grade ovarian carcinoma (HGOC) with germline or somatic BRCA mutations, treatment with rucaparib demonstrated activity with an acceptable safety profile, according to a pooled analysis presented at the 48th Annual Meeting of the Society of Gynecologic Oncology.1

Part 1 of the open-label, phase 2 ARIEL2 study (ClinicalTrials.gov Identifier: NCT01891344) showed that the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib was active in patients with relapsed, platinum-sensitive HGOC with a germline or somatic BRCA mutation. Part 2 evaluated rucaparib in patients who had received 3 to 4 prior lines of chemotherapy.

 

To evaluate the objective response rate and safety profile of rucaparib in this population, investigators of the ARIEL2 trial conducted a pooled analysis of parts 1 and 2. The researchers included only women who received a platinum agent as their last treatment and were sensitive to that treatment, and who had a somatic or germline BRCA mutation.

All participants received rucaparib 600 mg orally twice daily continuously in 28-day cycles until disease progression or unacceptable toxicity.

Results showed that 69.0% (95% CI, 55.5-80.5) of the 58 included patients achieved an objective response. Median duration of response was 9.2 months (95% CI, 6.4-12.9).

The study further demonstrated that 61.5% (95% CI, 40.6-

79.8), 90.0% (95% CI, 55.5–99.7), 75.0% (95% CI, 42.8–94.5), and 60.0% (95% CI 26.2–87.8) of women with a progression-free interval

of 6 to 9 months (n = 26), 9 to 12 months (n = 10), 12 to 18 months (n = 12), and greater than 18 months (n = 10) achieved an objective response, respectively.

The most frequently reported treatment-emergent adverse events were nausea, asthenia, vomiting, and anemia. Investigators observed no treatment-related deaths. 

The US Food and Drug Administration granted accelerated approval to rucaparib in 2016 for the single agent treatment of patients with deleterious germline and/or somatic BRCA mutation associated advanced ovarian cancer who have been treated with 2 or more chemotherapies.

Reference

1. Konecny GE, Oza AM, Tinker AV, et al. Rucaparib in patients with relapsed, primary platinum-sensitive high-grade ovarian carcinoma with germline or somatic BRCA mutations: Integrated summary of efficacy and safety from the phase II study ARIEL2. Paper presented at: 48th Annual Meeting of the Society of Gynecologic Oncology; March 12-15, 2017; National Harbor, MD.
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