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Onyx Pharmaceuticals Presents Carfilzomib Data at 53rd American Society of Hematology Annual Meeting
Date:12/12/2011

A Phase 1b/2 Study of Prolonged Infusion Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma: Updated Efficacy and Tolerability from the Completed 20/56 mg/m(2) Expansion Cohort of PX-171-007
The Phase 1b/2 study evaluated the safety and efficacy of a prolonged, 30-minute infusion of carfilzomib at a dose of 56mg/m(2) in 24 patients who previously had received a median of 4.5 lines of therapy. Authors observed a 60 percent ORR and an acceptable safety profile at this dose in these heavily pretreated patients.  These results support preclinical findings that longer infusion times enable higher doses and achieve greater levels of proteasome inhibition.

Abstract #3969: The Speed of Response to Single-Agent Carfilzomib in Patients with Relapsed and/or Refractory Multiple Myeloma: An Exploratory Analysis of Results from Two Multicenter Phase 2 Clinical Trials
An analysis of two Phase 2 studies demonstrated that the speed of response to carfilzomib was rapid. Rapid response was defined as achievement of minimal response or better within a median of 0.5 to 1.0 months. When results were analyzed according to baseline characteristics, there was a trend of longer times to clinical benefit response in patients with a greater number of prior therapeutic regimens.

About the Phase 2 Studies

  • 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: bortezomib-naive patients and patients previously treated with bortezomib. Prior therapies included alkylating agents, stem cell transplant, thalidomide, lenalidomide and anthracyclines, and bortezomib in the bortezomib-t
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SOURCE Onyx Pharmaceuticals, Inc.
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