SOUTH SAN FRANCISCO, Calif., July 25, 2012 /PRNewswire/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Blood, the medical journal of the American Society of Hematology, has published results from the 003-A1 Phase 2b trial, a single-arm, multicenter clinical trial evaluating Kyprolis™ (carfilzomib) for Injection for the treatment of patients with advanced multiple myeloma, who had received a median of five prior anti-myeloma regimens. The lead author was Dr. David Siegel, Chief of the Division of Multiple Myeloma at John Theurer Cancer Center at Hackensack University Medical Center.
On July 20, 2012, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. Full prescribing information is available at http://www.onyx.com.
About the 003-A1 Study
Two hundred and sixty-six patients with relapsed multiple myeloma who had received at least two prior therapies including bortezomib and an IMiD were enrolled in the open-label, single-arm 003-A1 Phase 2b study, and 257 patients were evaluable for response. The authors reported on the primary endpoint and secondary endpoints of the 003-A1 trial. The primary endpoint was overall response rate (ORR), defined as partial response (PR) or greater. The ORR was 23.7% among response-evaluable patients (n=257), and 22.9% among the total patient population (n=266). The median duration of response was 7.8 months. The most common treatment-emergent adverse events (AEs) reported in this study were fatigue (49%) and anemia (46%), and the most common Grade 3/4 AEs were thrombocytopenia (29%) and anemia (24%). The most common AEs of any grade possibly related to carfilzomib were fatigue (37%) and nausea (34%).