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Onyx Pharmaceuticals Announces Positive Complete Results From Carfilzomib Phase 2b Study
Date:12/7/2010

EMERYVILLE, Calif., Dec. 7, 2010 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced positive complete results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. Carfilzomib achieved an overall response rate (ORR) (partial response or greater) of 24.1 percent and a median duration of response (DOR) of 8.3 months in patients who entered the study after receiving a median of five prior lines of therapy (corresponding to a median of 13 anti-myeloma agents) and whose disease was refractory to their last therapeutic regimen. In addition, patients enrolled in the study had progressive disease upon entering the trial.  The clinical benefit rate (CBR) (minimal response or greater) in the study population was 34.2 percent.  The median overall survival (OS) was 15.5 months. Overall survival for responding patients (greater than or equal to minimal response) has not yet been reached; however, based on current data is expected to exceed 19 months.

Seventy-seven percent of patients had grade 1/2 peripheral neuropathy (PN) upon entry into the study.  New or worsening of PN was uncommon and Grade 3 PN occurred in less than 1 percent of patients. There were no Grade 4 PN events. A subset analysis of patients with PN (n= 202) on study was also presented at ASH.  Efficacy responses in patients with baseline PN were comparable to those seen in the full study population with an ORR of 24 percent and CBR of 34 percent. Based on the full 003-A1 results, Onyx plans to submit a New Drug Application (NDA) filing as early as mid-2011 for potential accelerated approval in the U.S.

These data are being presented today at the 52nd American Society of Hematology Annual Meeting in Orlando by David Siegel, M.D., Ph.D., Division Chief for Myelo
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SOURCE Onyx Pharmaceuticals, Inc.
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