US personalized cancer therapy specialist Clovis Oncology (Nasdaq: CLVS) on Sunday announced positive new data from parts 1 and 2 of the ongoing ARIEL2 Phase II study at the 2017 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in National Harbor, MD.
New data from these presentations include analyses of patient subsets from the ARIEL2 trial, including an integrated summary of data in patients from ARIEL2 parts 1 and 2 with a germline or somatic BRCA1 or BRCA2 (BRCA) mutation. ARIEL2 enrolled 493 patients with relapsed ovarian cancer to identify those patients most likely to respond to treatment with Rubraca (rucaparib): part 1 enrolled 206 patients who received one or more prior therapies, had platinum as their last treatment, and were platinum-sensitive; part 2 enrolled 287 patients treated with three or four prior therapies who were either platinum-sensitive, -resistant or -refractory at time of enrollment.
Rubraca, which is seen as having blockbuster potential, received accelerated approval from the US Food and Drug Administration in December 2016 as monotherapy for women with BRAC-mutated advanced ovarian cancer and Clovis has submitted the associated regulatory filing in the fourth quarter of 2016.
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