Rucaparib: Additional Phase I/II data

Final data from the dose-escalation Phase I portion of an open-label, U.S. and U.K. Phase I/II trial showed that ovarian cancer patients who received >=360 mg twice-daily oral rucaparib (n=12) had a disease control rate (DCR) of 83% at 24 weeks. The DCR was 82% in 11 patients with a germline breast cancer early onset (BRCA) mutation, 75% in 8 platinum-resistant patients and 100% in 4 platinum-sensitive patients. At the recommended Phase II dose of 600 mg rucaparib, 4 of 5 patients with germline BRCA mutations had an objective response, including 3 ovarian cancer patients and 1 breast cancer patient. There were no treatment-related discontinuations in the Phase I portion, which enrolled 56 patients with advanced solid tumors that had progressed on standard treatment. Clovis reported preliminary data from the Phase I portion last year (see BioCentury, June 10, 2013).

Preliminary data from 8 relapsed, platinum-sensitive ovarian cancer patients with germline BRCA mutations in the Phase II portion of the trial showed that rucaparib led to 4 partial responses. Additionally, 1 patient showed 18% lesion regression. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...