Seattle Genetics completes safety review for Phase IIb leukemia trial

After review of the collected data, the independent data monitoring committee did not identify any safety concerns and has recommended that the trial continue per the protocol.

This interim assessment was based on a planned evaluation of safety data from the first 50% of patients randomized in the study who received at least one dose of treatment. The company has completed approximately two-thirds of the total target enrollment of 210 patients, and expects to report data in the first half of 2010.

The lintuzumab Phase IIb clinical trial is a randomized, double-blind, placebo-controlled study designed to assess whether the combination regimen of lintuzumab and low-dose cytarabine chemotherapy extends overall survival compared to low-dose cytarabine alone in previously untreated patients 60 years of age and older who decline intensive chemotherapy. The study is enrolling patients at more than 80 clinical sites worldwide.

Lintuzumab is a humanized monoclonal antibody that targets the CD33 antigen, which is expressed on a number of hematologic malignancies, including acute myeloid leukemia (AML), myelodysplastic syndromes and several myeloproliferative disorders.

Thomas Reynolds, chief medical officer of Seattle Genetics, said: This is an important step for the lintuzumab program towards our goal of developing a therapeutic regimen for older AML patients, many of whom cannot tolerate the toxicities associated with standard high-dose chemotherapy, and where median survival is less than six months.

Demonstrating that the addition of lintuzumab leads to a meaningful survival advantage would be a significant advance in the care of older AML patients who have limited alternative therapies.