PX-171-003-A1, an open-label, single-arm, phase (Ph) II study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (R/R MM) Long-term follow-up and subgroup analysis

SUMMARY: KYPROLIS® (Carfilzomib) is a second generation proteasome inhibitor. Unlike VELCADE® (Bortezomib), proteasome inhibition with KYPROLIS® is irreversible. The approval of KYPROLIS® was based on a phase 2b, single-arm, multicenter clinical study in which 266 patients with advanced refractory Multiple Myeloma who had progressed on 2 or more prior therapies were evaluated. Prior therapies included treatment with VELCADE® (Bortezomib), REVLIMID® (Lenalidomide) or THALOMID® (Thalidomide). The primary end point was Overall Response Rate (ORR). The ORR with single agent KYPROLIS® was 24%, with a median duration of response of 7.4 months. This benefit was seen regardless of unfavorable cytogenetics. Peripheral neuropathy was infrequent and the most common adverse events were primarily hematologic. Patients with resistant and refractory Multiple Myeloma now have a new treatment option after a six year hiatus. Siegel DSD, Martin T, Wang M, et al. J Clin Oncol 29: 2011 (suppl; abstr 8027)