Carfilzomib: Phase IIb data
Top-line data from the open-label, North American pivotal Phase IIb PX-171-003-A1 trial in 266 patients showed that IV carfilzomib produced an ORR of 24%, with a median duration of response of 7.4 months and a CBR of 36%. Carfilzomib was well tolerated with no new or unexpected toxicities. Patients received twice-weekly 20 mg/m 2 IV carfilzomib for 3 weeks of the first 28-day cycle, followed by twice-weekly 27 mg/m 2 for 3 weeks in each subsequent 28-day cycle for up to 12 cycles. Onyx said it plans to submit an NDA to FDA by year end seeking accelerated approval for carfilzomib as a single agent to treat relapsed and refractory MM. Interim response data from 39 evaluable patients and interim safety data from 141 evaluable patients were reported last year (see BioCentury, June 15, 2009 & Dec. 21, 2009). Onyx gained carfilzomib through its acquisition of Proteolix Inc. in 2009 (see BioCentury, Nov. 23, 2009). ...