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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

), median time to tumor progression of 5.1 months and a median of 7.4 months response duration.

Based on the emerging safety profile, the 003-A0 protocol was amended in 2008 to permit increased dosing of up to 27 mg/m(2). The protocol was also expanded into the 003-A1 Phase 2b trial, enrolling 269 patients with relapsed and refractory myeloma and a dose escalation from 20 mg/m(2)( )to 27 mg/m(2)( )after one cycle. The primary endpoint for the Phase 2b 003-A1 pivotal study is overall response rate, and secondary endpoints include clinical benefit response, duration of response, progression-free survival, time-to-progression, overall survival and safety.

Dr. Jagannath presented new safety data on 141 patients in the 003-A1 trial, showing that carfilzomib was well tolerated at the 27 mg/m(2) dose. Grade 3/4 hematologic events included anemia (13.5 percent), thrombocytopenia (16.3 percent), neutropenia (3.5 percent), and febrile neutropenia (0.7 percent). The rate of grade 3/4 peripheral neuropathy was 0.7 percent. The regimen was well tolerated with prolonged administration of more than 12 cycles (48 weeks) in approximately 10% of patients, and no clinically significant cumulative toxicities have been noted to date. Both portions of the trial are being conducted in collaboration with the Multiple Myeloma Research Consortium.

Investor Teleconference

Principal investigators will discuss data presentations surrounding carfilzomib in relapsed or refractory multiple myeloma, as featured at ASH. The webcast event will begin at 9:00 a.m. CT/10:00 a.m. ET on December 7, 2009. The live webcast will be available at:

http://www.onyx-pharm.com/view.cfm/32/Event-Calendar

or by dialing 847-413-3362 and using the passcode 25914947. A replay of the presentation will be available on the Onyx website or by dialing 630-652-30
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SOURCE Onyx Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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