Genmab announced today top-line results from the Phase II study of Arzerra in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients
Copenhagen, Denmark | August 11, 2009 | Genmab A/S (OMX: GEN) announced today top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events, was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.
"We are pleased to see the positive results of this first study investigating ofatumumab for the treatment of front line CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We look forward to presenting the full data at a future medical meeting."
About the study
Patients in this open label study were randomized into two treatment groups. Each patient was to receive one infusion of 300 mg of ofatumumab in combination with FC followed by 5 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status was measured every 4 weeks until week 24 and every 3 months thereafter until disease progression or 24 months. Treatment response was assessed according to the 1996 National Cancer Institute Working Group guidelines by an Independent endpoints Review Committee. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 60 months.
The objective of the study was to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint was complete remission rate from start of treatment until 3 months after last infusion.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
SORUCE: Genmab
Post Views: 73
Genmab announced today top-line results from the Phase II study of Arzerra in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients
Copenhagen, Denmark | August 11, 2009 | Genmab A/S (OMX: GEN) announced today top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.
There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events, was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.
"We are pleased to see the positive results of this first study investigating ofatumumab for the treatment of front line CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We look forward to presenting the full data at a future medical meeting."
About the study
Patients in this open label study were randomized into two treatment groups. Each patient was to receive one infusion of 300 mg of ofatumumab in combination with FC followed by 5 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status was measured every 4 weeks until week 24 and every 3 months thereafter until disease progression or 24 months. Treatment response was assessed according to the 1996 National Cancer Institute Working Group guidelines by an Independent endpoints Review Committee. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 60 months.
The objective of the study was to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint was complete remission rate from start of treatment until 3 months after last infusion.
About ofatumumab
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
SORUCE: Genmab
Post Views: 73
