National Harbor, MD. – The PARP inhibitor rucaparib is safe and effective in patients with primary platinum-sensitive high-grade ovarian carcinoma who have germline or somatic BRCA mutations, according to integrated summary data from parts 1 and 2 of the phase II ARIEL2 study.
Prior analyses of ARIEL2 data included 493 patients with germline/somatic BRCA mutations and BRCA wild-type. The current analysis included the 41 patients from ARIEL2 part 1 and the 93 patients from ARIEL2 part 2 who had germline or somatic BRCA mutations, and overall response rates in these patients ranged from 52% to 86% depending on the number of prior therapies, Gottfried E. Konecny, MD, reported at the annual meeting of the Society of Gynecologic Oncology.
The highest overall response rates were seen in platinum-sensitive vs. platinum-resistant and platinum-refractory patients, said Dr. Konecny of the University of California, Los Angeles.
Median progression-free survival was 12.7 months in the platinum-sensitive patients vs. 7.3 and 5.0 months in platinum-resistant and platinum-refractory patients, respectively, he said.
Treatment was generally safe and well tolerated. The most common treatment-emergent adverse events were nausea, fatigue, vomiting, and anemia; the most common grade 3/4 events included anemia, increased ALT/AST, and fatigue.
Previous findings from ARIEL2 and other studies of rucaparib led to conditional approval of the drug (pending further confirmation of the data), first for patients with germline or somatic BRCA mutations who fail at least three prior lines of chemotherapy, then for those who fail two or more prior therapies.
In this video, Dr. Konecny discusses his findings and the next steps with respect to the study of rucaparib for high-grade ovarian carcinoma.
ARIEL2 was supported by Clovis Oncology. Dr. Konecny is on the speakers’ bureau for AstraZeneca and Clovis Oncology and has received research funding or honorarium from Amgen, Merck, and Novartis.