Rucaparib: Additional Phase II data

Pooled data from 106 patients with germline or somatic breast cancer early onset (BRCA)-mutated advanced ovarian cancer who received >=2 prior chemotherapies, including >=2 platinum-based regimens, in the open-label, international Phase II ARIEL2 trial (n=64) or the Phase II portion of the Phase I/II Study 10 (n=42) showed that twice-daily 600 mg rucaparib led to an ORR of 54%, including 9 complete responses and 48 partial responses, plus 36 cases of stable disease. The median duration of response was 9.2 months and median PFS was 10 months. Additionally, 6- and 12-month PFS rates were 79% and 41%, respectively.

In patients with a BRCA1 (n=67) or BRCA2 (n=39) mutation, rucaparib led to an ORR of 54%. In patients with germline BRCA mutations (n=88) and somatic BRCA mutations (n=13), rucaparib led to an ORR of 53% and 46%, respectively. In patients who received 2 prior chemotherapies (n=41) and in patients who received 2 prior platinum regimens (n=60), rucaparib led to an ORR of 68% and 65%, respectively. In platinum-refractory patients (n=7), platinum-resistant patients (n=20) and platinum-sensitive patients (n=79), rucaparib led to an ORR of 0%, 25% and 66%, respectively. Data were presented at the European Society for Medical Oncology meeting in Copenhagen. Clovis previously reported data from the ARIEL2 and Study 10 (see BioCentury, June 10, 2013; July 21, 2014; Oct. 6, 2014; Nov. 24, 2014 & June 29, 2015). ...