Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (Nasdaq:SGEN - News) today announced that the Journal of Clinical Oncology (JCO) published results of the companys pivotal clinical trial of ADCETRIS (brentuximab vedotin) in Hodgkin lymphoma (HL) patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT). The findings, published today online, demonstrated that treatment with ADCETRIS as a single agent induced durable objective responses in 75 percent of patients and was associated with a manageable safety profile. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in HL and anaplastic large cell lymphoma (ALCL).

Additionally, a separate pivotal clinical trial of ADCETRIS for the treatment of relapsed or refractory systemic ALCL has been accepted for publication and is currently in press for an upcoming issue of JCO.

Although Hodgkin lymphoma is often viewed as a curable disease, up to 30 percent of patients relapse or are refractory following front-line chemotherapy regimens and subsequent treatments, leaving limited therapeutic options, said Dr. Anas Younes, Professor of Medicine and Director, Clinical Investigation and Translational Research Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. ADCETRIS represents a new approach that is changing the way we treat relapsed and refractory HL patients. The complete response rate and manageable safety profile we observed with ADCETRIS in the pivotal trial have also generated enthusiasm among the medical community for evaluating ADCETRIS in earlier lines of HL therapy.

Data from this pivotal trial served as the basis for the accelerated approval of ADCETRIS in August 2011 for relapsed Hodgkin patients, and is the foundation for our robust clinical development plan to broadly evaluate ADCETRIS in earlier lines of therapy, as well as in other CD30-positive malignancies, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. We are evaluating ADCETRIS across a broad array of CD30-positive malignancies, towards our goal of bringing it to additional patients in need.

The open-label, phase II study evaluated the efficacy and safety of ADCETRIS in 102 patients with relapsed or refractory, CD30-positive HL after ASCT.

Highlights from the study include:

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS is being evaluated in a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT), a phase II trial for relapsed or refractory CD30-positive non-Hodgkin lymphomas, a phase II trial for CD30-positive non-lymphoma malignancies, a phase II retreatment trial for relapsed patients who previously responded to ADCETRIS, a phase I trial in combination with multi-agent chemotherapy for front-line treatment of Hodgkin lymphoma and a phase I trial in combination with multi-agent chemotherapy for front-line treatment of mature T-cell lymphomas. Three additional phase III trials are planned, including a trial in CD30-positive cutaneous T-cell lymphomas to begin in mid-2012, a front-line trial in Hodgkin lymphoma and a front-line trial in mature T-cell lymphomas. The front-line trials are expected to begin by late 2012 or early 2013.

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Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ...