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Onyx Pharmaceuticals Presents Interim Results of Phase 1b Carfilzomib Combination Trial
Date:6/4/2010

pretreated group of patients with myeloma, with no overlapping toxicities with the treatment triplet.  We look forward to further study of this important carfilzomib-based combination regimen in the upcoming international Phase 3 trial."

Additional Phase 1b Trial Results

The study was designed to evaluate the safety, maximum tolerated or maximum per-protocol doses, and efficacy of carfilzomib in combination with lenalidomide and low-dose dexamethasone.  Forty patients were enrolled in the dose-escalation portion of this study (cohorts 1-6).  Doses were escalated from 15mg/m2 carfilzomib and 10mg lenalidomide to the maximum per-protocol doses of 27 mg/m2 carfilzomib and 25mg lenalidomide.  A total of fifty-two patients received the maximum per-protocol doses, including eight patients in cohort 6 and forty-four patients in the expansion cohort.  All patients enrolled in the study received 40mg low dose dexamethasone.

Of the 84 patients in the trial, 79 percent had received more than two prior treatment regimens for myeloma with 74 percent of the patients having received prior bortezomib, 87 percent prior immunomodulatory drug therapy (67 percent prior lenalidomide and 44 percent prior thalidomide), and 98 percent prior steroids.

Side effects were clinically manageable and generally consistent with those typically seen with the agents that were combined with carfilzomib.  Grade 3/4 adverse events included neutropenia (23 percent), thrombocytopenia (18 percent), anemia (12 percent), and hyperglycemia (5 percent).  The triple combination regimen was well tolerated and prolonged administration (14-23 months) without interruption was possible, allowing for durable disease control. Initial responses typically occurred within the first cycle, with many patients showing even greater improvement over the subs
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SOURCE Onyx Pharmaceuticals, Inc.
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