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Human Genome Sciences Reports Initial Results of Randomized Phase 2 Trial of HGS-ETR1 in Combination With Bortezomib in Advanced Multiple Myeloma
Date:9/2/2008

ed in the study, which is being conducted in the United States, Canada, Australia and India. Patients were randomized into three treatment groups, with one group receiving bortezomib alone and two groups receiving bortezomib in combination with mapatumumab (10 mg/kg or 20 mg/kg). Approximately 43% (15/35) of the patients in the group receiving bortezomib alone were randomized contemporaneously with randomization of the group receiving a combination of bortezomib and mapatumumab at 10 mg/kg. The remaining 57% (20/35) of the patients in the group receiving bortezomib alone were randomized contemporaneously with randomization of the group receiving a combination of bortezomib and mapatumumab at 20 mg/kg. The primary objective of the study is to evaluate disease response to mapatumumab in combination with bortezomib, versus bortezomib alone, in patients with relapsed or refractory multiple myeloma. Secondary objectives include evaluation of progression-free survival, safety and tolerability, and plasma concentrations of mapatumumab for use in a population pharmacokinetic analysis.

Patients participating in the study had received a median of 2 previous cancer treatment regimens. At baseline, 17.1% (6/35) of patients in the treatment group receiving bortezomib alone had Stage 3 disease, vs. 40.6% (13/33) in the group receiving the combination of bortezomib and mapatumumab at 10 mg/kg, and 19.4% (7/36) in the group receiving the combination of bortezomib and mapatumumab at 20 mg/kg. The initial data show that mapatumumab was well tolerated and could be administered safely and repetitively in combination with bortezomib, with no evidence of increased toxicity in patients receiving the combination of bortezomib and mapatumumab, vs. patients receiving bortezomib alone.

Overall, based on initial data, disease response was comparable among the three treatment groups, including the following findings:

-- Three complete responses (8.3%; N=36) were observed am
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SOURCE Human Genome Sciences, Inc.
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