Seattle Genetics, Inc. (Nasdaq:SGEN) announced that data from a phase I clinical trial evaluating every three week dosing of SGN-35 and a phase I clinical trial of lintuzumab (SGN-33) will be reported at the 14th Congress of the European Hematology Association (EHA) being held June 4-7, 2009 in Berlin, Germany. The abstracts are available from the EHA website at ehaweb.
“In our SGN-35 presentation at EHA, we will provide additional data on durability of response and progression-free survival of patients in our every three week dosing study,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “In addition, we will report a strong concordance between investigator-assessed and independent review of responses in the trial.”
The SGN-35 abstract is titled “Robust antitumor activity of the antibody-drug conjugate SGN-35 when administered every three weeks to patients with relapsed or refractory CD30-positive hematologic malignancies in a phase I study,” (Abstract #503). Updated data will be presented in an oral presentation on June 6, 2009, during a clinical session on Hodgkin lymphoma.
Seattle Genetics is advancing SGN-35 in an ongoing pivotal trial for relapsed and refractory Hodgkin lymphoma and a planned phase II trial for systemic anaplastic large cell lymphoma. The pivotal trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). SGN-35 is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in targeted cell-killing.
The lintuzumab abstract, #833, is titled “Prolonged exposure to lintuzumab monotherapy in acute myeloid leukemia and myelodysplastic syndromes – results of a phase I trial.” The data will be presented in an acute myeloid leukemia (AML) poster session on June 6, 2009.
“The presentation on lintuzumab will provide complete data from our phase I single-agent clinical trial in more than 80 patients,” added Dr. Reynolds. “Findings will include data on the tolerability profile and objective responses with lintuzumab as monotherapy in AML and myelodysplastic syndromes, primarily in older patients who were not candidates for intensive therapies.”
Lintuzumab is a humanized monoclonal antibody targeting CD33. Seattle Genetics is conducting a phase IIb randomized, double-blind, placebo-controlled clinical trial 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.
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Seattle Genetics