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Carfilzomib Safety Data From Ongoing Phase 2b Pivotal Trial in Relapsed and Refractory Multiple Myeloma Show Promising Safety and Tolerability
Date:12/6/2009

NEW ORLEANS, Dec. 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced updated safety data from the pivotal Phase 2b 003-A1 study, known as the 003 trial, demonstrating that carfilzomib is well-tolerated in heavily pre-treated relapsed and refractory multiple myeloma patients. These data were presented today at the ASH/ASCO Joint Symposium at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans. Enrollment in this trial is complete (n=269), and full results, expected in 2010, could support a potential new drug application (NDA) filing by year-end 2010.

"These results show that carfilzomib is well-tolerated and can be administered at a full dose over a long period of time even in a very sick patient population for whom all available treatment options have been exhausted and who have multiple comorbidities," said lead investigator Sundar Jagannath, M.D., chief of the Multiple Myeloma Program, Bone Marrow and Blood Stem Cell Transplantation at St. Vincent's Comprehensive Cancer Center in New York. "We look forward to the full data from this trial next year."

Dr. Jagannath also presented results from the Phase 2 003-A0 study, which recruited patients whose myeloma had relapsed from two or more prior therapies and was refractory to their previous therapy. This study is the lead-in study for the current Phase 2b registrational trial in the same population. Data from this study was initially presented at the American Society for Clinical Oncology (ASCO) annual meeting in June 2009. Patients in the study had a median of five prior therapies. Previously presented efficacy data from 39 evaluable patients in the 003-A0 pilot study included an 18 percent overall response rate (partial response or better) and a 26 percent clinical benefit rate (minor response or better
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SOURCE Onyx Pharmaceuticals, Inc.
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