Seattle Genetics' lintuzumab phase IIb clinical trial for AML does not meet primary endpoint

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its phase IIb clinical trial of lintuzumab (SGN-33) in older patients with acute myeloid leukemia (AML) did not meet its primary endpoint of extending overall survival. Lintuzumab is a naked monoclonal antibody that targets the CD33 antigen. As a result of the outcome of this trial, the company will discontinue its development program for lintuzumab.

“There is a lot of positive momentum at Seattle Genetics and we continue to focus on advancing our lead product candidate, brentuximab vedotin (SGN-35), and our robust pipeline”

"We are disappointed that lintuzumab did not demonstrate a survival benefit for older AML patients in this study. These patients have limited therapeutic alternatives due to their inability to tolerate the toxicities associated with standard high-dose chemotherapy, representing a substantial unmet medical need," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "We want to thank the patients, caregivers and investigators for their participation and commitment to the clinical evaluation of lintuzumab."

"There is a lot of positive momentum at Seattle Genetics and we continue to focus on advancing our lead product candidate, brentuximab vedotin (SGN-35), and our robust pipeline," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are on track to report top-line data from two brentuximab vedotin clinical trials within the next six weeks, positioning us for a regulatory submission in the first half of 2011. In addition, our strong financial position allows us to continue to invest in advancing our multiple other programs, including two antibody-drug conjugates, SGN-75 and ASG-5ME, which are both in ongoing phase I clinical trials."