ATLANTA--(BUSINESS WIRE)--
Seattle Genetics, Inc. (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 54th 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.
Brentuximab Vedotin Administered Concurrently with Multi-Agent Chemotherapy as Front-line Treatment of ALCL and Other CD30-Positive Mature T-Cell and NK-Cell Lymphomas (Abstract #60)
Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP. Nineteen patients had sALCL, and seven patients had a diagnosis of another mature T- or NK-cell lymphoma. The median age of patients was 56 years. Key findings, which were highlighted in an oral presentation by Dr. Fanale, include:
These data provide strong rationale for our planned phase III clinical trial to evaluate ADCETRIS plus CHP compared to CHOP in front-line patients with mature T-cell lymphomas, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. We are encouraged by the potential to introduce ADCETRIS into a novel regimen for these patients, with a goal of redefining front-line therapy from the standard therapeutic approach that has not seen an advance in decades.
A phase III clinical trial of ADCETRIS in CD30-positive MTCL patients is planned to compare progression-free survival in patients receiving ADCETRIS in combination with CHP (A+CHP) to patients receiving CHOP alone. The trial is expected to begin by late 2012 or early 2013.
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Seattle Genetics Reports Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Front-line Mature T-Cell ...