Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that an Independent Data Monitoring Committee (IDMC) has completed a pre-specified safety review of data from the ongoing phase IIb trial of lintuzumab (SGN-33) in combination with low-dose cytarabine chemotherapy for older patients with acute myeloid leukemia (AML). After review of the collected data, the IDMC did not identify any safety concerns and has recommended that the trial continue per the protocol. This interim assessment was based upon a planned evaluation of safety data from the first 50 percent 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.
“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,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “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.”
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 AML, myelodysplastic syndromes (MDS) and several myeloproliferative disorders. Seattle Genetics reported data from a completed phase Ia dose-escalation clinical trial of lintuzumab demonstrating multiple complete responses at well-tolerated doses. In addition to the phase IIb clinical trial, Seattle Genetics is conducting a phase Ib trial of single-agent lintuzumab in patients with AML or MDS and a phase I trial of lintuzumab in combination with Revlimid® (lenalidomide) for advanced MDS.
AML is the most common type of acute leukemia in adults. According to the American Cancer Society, an estimated 13,000 new cases of AML will be diagnosed in the United States in 2008. Approximately two-thirds of AML patients are over 60 years of age at diagnosis, many of whom are unable to tolerate the toxic side effects of intensive chemotherapy. AML results in uncontrolled growth and accumulation of malignant cells, or “blasts,” which fail to function normally and block the production of normal blood cells, leading to a deficiency of red cells (anemia), platelets (thrombocytopenia) and normal white cells (neutropenia) in the blood.
About Seattle Genetics
Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company has four product candidates in ongoing clinical trials: dacetuzumab (SGN-40), lintuzumab (SGN-33), SGN-35 and SGN-70. Dacetuzumab is being developed under a worldwide collaboration with Genentech. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprising highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, Daiichi Sankyo and MedImmune, a subsidiary of AstraZeneca, as well as an ADC co-development agreement with Agensys, a subsidiary of Astellas Pharma. More information can be found at seattlegenetics.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of lintuzumab and expectations of completing enrollment of the trial. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient safety or activity in clinical trials of lintuzumab and the risk of adverse clinical results as lintuzumab advances in such clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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