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Onyx Pharmaceuticals Provides Update on Carfilzomib at 53rd American Society of Hematology Annual Meeting
Date:12/10/2011

d but variable adverse impact on therapeutic response and time to event. Of the 229 evaluable patients, 71 patients had unfavorable cytogenetic status. Cytogenetic abnormalities are defined as the presence of del 13 or hypodiploidy by metaphase cytogenetic analysis and/or del 17p13, t(4;14), t (14;16) by fluorescence in situ hybridization (FISH).  An analysis of the results showed that response rates to carfilzomib among patients with normal/favorable cytogenetics were comparable to rates among patients with unfavorable cytogenetic abnormalities.

About the Phase 2 studies

  • The 003-A0 study was an open-label, single-arm, Phase 2 study of carfilzomib in patients with relapsed and refractory multiple myeloma. The primary endpoint was ORR, and secondary endpoints included CBR, DOR, PFS, TTP and safety. Patients in the 003-A0 trial received carfilzomib at a dose of 20mg/m(2).
  • The 003-A1 study was an open-label, single-arm Phase 2b trial. The trial evaluated 266 heavily-pretreated patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including bortezomib and either thalidomide or lenalidomide. Refractory disease was defined as less than or equal to a 25 percent response or progression during therapy, or progression within 60 days after completion of therapy.[i]  Patients received carfilzomib at a dose of 20mg/m(2) for the first cycle, and were then dose-escalated to 27mg/m(2). The primary endpoint was ORR. Secondary endpoints included DOR, CBR, OS, TTP, PFS, and safety. 
  • The 004 study, an open-label, single-agent Phase 2 study of carfilzomib, was conducted in collaboration with the Multiple Myeloma Research Consortium (MMRC) and other institutions, and enrolled 129 patients with relapsed and/or refractory multiple myeloma who had received one to three prior treatments. Patients were divided into two populations:
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SOURCE Onyx Pharmaceuticals, Inc.
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