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

cluded that these data confirm and extend earlier results indicating that single-agent carfilzomib has an acceptable safety profile in heavily pretreated patients with relapsed and refractory multiple myeloma. Carfilzomib was associated with a low rate of typically mild to moderate, non dose-limiting peripheral neuropathy (PN). PN of any grade was reported in 73 patients (14 percent) across the studies, and one patient (<1 percent) discontinued treatment due to a PN-related adverse event. In regard to renal events, less than 1 percent of patients discontinued treatment due to a renal event and 87 percent of patients had no worsening of renal function. Investigator-assessed cardiac events, some of which resulted in death possibly related to carfilzomib (<1 percent) or treatment discontinuation, were reported in this heavily pretreated, late-stage population. Cardiac failure events were reported in 7 percent of patients regardless of causality. Cardiac events resulting in treatment discontinuation included congestive heart failure (2 percent), cardiac arrest (1 percent) and myocardial ischemia (<1 percent). The extent to which cardiac events were due to patients' baseline comorbidities, toxicity from prior treatments, effects of multiple myeloma, carfilzomib itself, or a combination of these factors could not be determined. Rates and causes of death were consistent with those observed in heavily pretreated patients with end-stage multiple myeloma.

Abstract #1875: Unfavorable Cytogenetic Characteristics do not Adversely Impact Response Rates in Patients with Relapsed and/or Refractory Multiple Myeloma Treated with Single-Agent Carfilzomib on the 003-A1 Study
This analysis evaluated the impact of specific cytogenetic abnormalities on efficacy and treatment outcomes including response rates, time-to-event endpoints, and OS. In patients with multiple myeloma, cytogenetic abnormalities with certain genetic variations have a well-documente
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