Seattle Genetics, Inc. (Nasdaq: SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL). The data were presented at the 54 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is not currently approved for use in the front-line treatment of MTCL.
In the phase I trial, newly diagnosed patients received six cycles of ADCETRIS every three weeks in combination with cyclophosphamide, doxorubicin and prednisone (CHP). This regimen removes vincristine (Oncovin) from CHOP, the standard treatment in this setting. Patients who achieved at least a partial remission after completing six cycles of combination therapy were eligible to receive continued single-agent ADCETRIS for up to ten additional 3-week cycles. The primary endpoints of the trial included defining maximum tolerated dose of ADCETRIS in combination with CHP and evaluating safety. The secondary endpoints were investigator assessment of response, progression-free survival and overall survival.
After completing combination therapy, 26 of 26 patients (100 percent) treated with ADCETRIS plus CHP had an objective response, including 23 patients (88 percent) with a complete remission. All 23 patients who achieved a complete remission demonstrated normalized glucose uptake by PET (positron emission tomography) evaluation.
“The standard front-line regimen for patients with mature T-cell lymphomas is a combination chemotherapy regimen, CHOP, that has demonstrated complete remission rates of 39 to 53 percent, with a 5-year overall survival rate of less than 50 percent,” said Michelle Fanale, M.D., Associate Professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “There is significant need to advance the treatment paradigm for newly diagnosed patients with these aggressive types of lymphoma. Data from this trial support further evaluation of ADCETRIS in the front-line treatment of patients with mature T-cell lymphomas.”