Ph IIb lintuzumab trial passes interim review

US drug developer Seattle Genetics says that a Phase IIb trial of lintuzumab (SGN-33) plus low-dose cytarabine for older patients with acute myeloid leukemia has passed its interim safety review without any concerns.

This assessment was based upon an 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 subjects, 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 people at more than 80 clinical sites worldwide. Company chief medical officer Thomas Reynolds said: "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."