Phase II clinical trial of Trail receptor antibody HGS-ETR1 in combination with bortezomib
Human Genome Sciences has reported initial topline results from an ongoing randomized Phase II clinical trial of its Trail receptor antibody HGS-ETR1 in combination with bortezomib in patients with advanced multiple myeloma.
The initial data from the multiple myeloma study show that HGS-ETR1 was well tolerated and suggest that disease response was comparable for this combination versus bortezomib alone. The trial in advanced multiple myeloma is a randomized, multi-center, open-label Phase II study to evaluate the efficacy and safety of HGS-ETR1 (mapatumumab) in combination with bortezomib in these patients.
Approximately 104 patients are being treated in the study, which is being conducted in the US, 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 (10mg/kg or 20mg/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 10mg/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 20mg/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.
Patients participating in the study had received a median of two previous cancer treatment regimens. At baseline, 17.1% (6/35) of patients in the treatment group receiving bortezomib alone had stage 3 disease, versus 40.6% (13/33) in the group receiving the combination of bortezomib and mapatumumab at 10mg/kg, and 19.4% (7/36) in the group receiving the combination of bortezomib and mapatumumab at 20mg/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, versus patients receiving bortezomib alone.
The initial data from the multiple myeloma study show that HGS-ETR1 was well tolerated and suggest that disease response was comparable for this combination versus bortezomib alone. The trial in advanced multiple myeloma is a randomized, multi-center, open-label Phase II study to evaluate the efficacy and safety of HGS-ETR1 (mapatumumab) in combination with bortezomib in these patients.
Approximately 104 patients are being treated in the study, which is being conducted in the US, 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 (10mg/kg or 20mg/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 10mg/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 20mg/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.
Patients participating in the study had received a median of two previous cancer treatment regimens. At baseline, 17.1% (6/35) of patients in the treatment group receiving bortezomib alone had stage 3 disease, versus 40.6% (13/33) in the group receiving the combination of bortezomib and mapatumumab at 10mg/kg, and 19.4% (7/36) in the group receiving the combination of bortezomib and mapatumumab at 20mg/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, versus patients receiving bortezomib alone.
posted by gwg at 11:57 AM
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