Carfilzomib: Phase II
Interim data from 33 evaluable patients with relapsed and/or refractory MM previously treated with Velcade bortezomib in the ongoing open-label Phase II 004 trial showed that 20 mg/m 2 IV carfilzomib produced an ORR of 18%, including 1 complete response, 1 very good partial response and 4 partial responses. Additionally, 4 minor responses and 13 cases of stable disease were reported. The median time to disease progression was 5.3 months. The most common grade 3/4 adverse events were anemia (14%) and neutropenia (11%).
In a second arm of 73 evaluable Velcade-naïve patients, 20 mg/m 2 (n=54) resulted in a 46% ORR and 27 mg/m 2 (n=19) resulted in a 53% ORR. The lower dose cohort had a time to progression of 7.6 months and a duration of response of 8.4 months. Previously reported data from 51 evaluable patients in this arm showed that 20 mg/m 2 carfilzomib produced an ORR of 45% (see BioCentury, November 16). ...