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

Seattle Genetics, Inc. (SGEN) today announced the initiation of a phase II clinical trial evaluating ADCETRIS (brentuximab vedotin) as a front-line therapy for patients age 60 or older with newly diagnosed Hodgkin lymphoma (HL). The trial is designed to assess the efficacy and tolerability of ADCETRIS as a monotherapy for older HL patients who have received no prior treatment. Seattle Genetics is the leader in the field of antibody-drug conjugates (ADCs) and ADCETRIS is an ADC directed to CD30 for relapsed HL and systemic anaplastic large cell lymphoma (sALCL).

The current standard of care for the treatment of front-line HL is a combination of multiple chemotherapeutic agents and has not changed in more than three decades. Some older HL patients are not able to tolerate the significant side effects associated with these regimens, and there is a significant need to identify effective and tolerable treatment options for these patients, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer at Seattle Genetics. We believe the response rate associated with single-agent use of ADCETRIS in the relapsed HL setting supports the evaluation of single-agent ADCETRIS in older patients who have received no prior therapy.

The phase II single-arm, open-label clinical trial will evaluate the efficacy and tolerability of ADCETRIS as front-line monotherapy in patients age 60 or older with HL. The trial is enrolling patients who are newly diagnosed and have received no prior HL treatment. The primary endpoint of the trial is to assess the objective response rate (ORR), with key secondary endpoints of safety and tolerability, duration of response, complete remission (CR) rate and progression-free survival (PFS). The study is expected to enroll up to 20 patients at multiple centers in the United States.

More information about the trial, including enrolling centers, will be available by visiting http://www.clinicaltrials.gov.

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 received accelerated approval from the U.S. Food and Drug Administration (FDA) for two indications: (1) the treatment of patients with HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

ADCETRIS is not approved for use outside the United States. The marketing authorization application for ADCETRIS in relapsed or refractory HL and sALCL, filed by Takeda Global Research & Development Centre (Europe), was accepted for review by the European Medicines Agency (EMA) in June 2011. In July 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued a positive opinion for the conditional approval of ADCETRIS, supporting an approval decision in the European Union.

Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

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Seattle Genetics Announces Initiation of Phase II Trial of ADCETRIS® as Front-line Therapy for Hodgkin Lymphoma ...