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

Oncology Division, Bone Marrow Transplantation & Leukemia Section at the Washington University School of Medicine, who presented the data. "The efficacy and safety results from this study suggest that carfilzomib has the potential to be used in earlier lines of treatment in patients with multiple myeloma."

Patients were divided into two cohorts. In Cohort 1 (n=59), patients received 20mg/m(2) for all treatment cycles.  In Cohort 2 (n=67), patients received a dose-escalating regimen of 20mg/m(2) for the first cycle and 27mg/m(2) for all remaining treatment cycles.

The 59 evaluable patients who received carfilzomib at 20mg/m(2) achieved an ORR of 42 percent and a CBR of 59 percent. This cohort demonstrated a TTP of 8.3 months and a DOR of 13.1 months. The median overall survival (OS) has not yet been reached.  Sixty-six percent of these patients were refractory to their most recent therapy prior to entering the trial.

No new or unexpected adverse events were observed. The most common Grade 3 treatment-emergent adverse events included: anemia (Cohort 1, 12 percent; Cohort 2, 17 percent); thrombocytopenia (Cohort 1, 15 percent; Cohort 2, 11 percent); neutropenia (Cohort 1, 12 percent; Cohort 2, 14 percent); lymphopenia (Cohort 1, 14 percent; Cohort 2, 19 percent); and pneumonia (Cohort 1, 14 percent; Cohort2, 11 percent). Peripheral neuropathy of any grade was infrequent.

"This trial highlights our commitment to understanding carfilzomib across treatment settings," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations at Onyx Pharmaceuticals. "Efficacy and safety data from this trial was included as part of the New Drug Application (NDA) for carfilzomib that was recently accepted by the U.S. Food and Drug Administration (FDA) under the accelerated approval process for the treatment of patients with relapsed and refractory multiple myeloma."

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SOURCE Onyx Pharmaceuticals, Inc.
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