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Seattle Genetics Presents Final Lintuzumab Phase I Clinical Data
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Seattle Genetics, Inc. has reported multiple objective responses at well-tolerated doses from a phase I clinical trial of lintuzumab (SGN-33) in patients with acute myeloid leukemia (AML).
The data were presented at the 14th Congress of the European Hematology Association (EHA) being held in Berlin, Germany. Lintuzumab is a humanized monoclonal antibody that targets the CD33 antigen, which is expressed on a number of hematologic malignancies, including AML and myelodysplastic syndromes (MDS).
“We are pleased by the findings from this large single-agent phase I trial demonstrating that lintuzumab was well-tolerated and induced objective responses in patients with AML,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We continue to believe that the path forward with lintuzumab will be as a combination agent, and our clinical development program is focused primarily on a phase IIb trial combining lintuzumab with low-dose chemotherapy to determine if lintuzumab can extend overall survival in older AML patients.”
Seattle Genetics is conducting a phase IIb randomized, double-blind, placebo-controlled clinical trial of lintuzumab. The study is evaluating whether the combination of lintuzumab and low-dose cytarabine chemotherapy extends overall survival compared to low-dose cytarabine plus placebo in previously untreated AML patients age 60 and older who decline intensive chemotherapy.
Full accrual of 210 patients to the phase IIb trial is complete, and data are expected in the first half of 2010. The company is also evaluating lintuzumab for MDS, including a phase I trial in combination with Revlimid® (lenalidomide) and a planned phase II clinical trial combined with Vidaza® (azacitidine).
The data were presented at the 14th Congress of the European Hematology Association (EHA) being held in Berlin, Germany. Lintuzumab is a humanized monoclonal antibody that targets the CD33 antigen, which is expressed on a number of hematologic malignancies, including AML and myelodysplastic syndromes (MDS).
“We are pleased by the findings from this large single-agent phase I trial demonstrating that lintuzumab was well-tolerated and induced objective responses in patients with AML,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We continue to believe that the path forward with lintuzumab will be as a combination agent, and our clinical development program is focused primarily on a phase IIb trial combining lintuzumab with low-dose chemotherapy to determine if lintuzumab can extend overall survival in older AML patients.”
Seattle Genetics is conducting a phase IIb randomized, double-blind, placebo-controlled clinical trial of lintuzumab. The study is evaluating whether the combination of lintuzumab and low-dose cytarabine chemotherapy extends overall survival compared to low-dose cytarabine plus placebo in previously untreated AML patients age 60 and older who decline intensive chemotherapy.
Full accrual of 210 patients to the phase IIb trial is complete, and data are expected in the first half of 2010. The company is also evaluating lintuzumab for MDS, including a phase I trial in combination with Revlimid® (lenalidomide) and a planned phase II clinical trial combined with Vidaza® (azacitidine).
