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

Seattle Genetics, Inc. (SGEN) today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 9th International Symposium on Hodgkin Lymphoma (ISHL) being held October 12-15, 2013 in Cologne, Germany. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2011 for relapsed HL and sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and sALCL.

Since the last ISHL meeting in 2010, we have made significant progress in advancing ADCETRIS, including approvals in 35 countries to date for the treatment of relapsed HL and sALCL, said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. In addition, we are evaluating ADCETRIS broadly in more than 20 ongoing clinical trials, including four global phase 3 trials in earlier lines of therapy for HL and mature T-cell lymphoma, as well as relapsed cutaneous T-cell lymphoma. Our goal is to establish ADCETRIS as the foundation of therapy for CD30-positive malignancies and improve the therapeutic outcome for patients.

Three oral and nine poster presentations at ISHL illustrate the broad clinical development program for ADCETRIS in HL, including data from a phase 1 frontline advanced HL trial and a poster presentation describing the ongoing global phase 3 ECHELON-1 clinical trial in frontline HL. ADCETRIS is currently not approved for use in the treatment of newly diagnosed HL.

Frontline HL Data Presentations: Corporate-sponsored Trials

Frontline Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma, (P005) by Dr. Stephen Ansell, Professor of Medicine, Division of Hematology, Mayo Clinic

This phase 1 trial was conducted to evaluate ADCETRIS plus the chemotherapy regimen ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or ADCETRIS plus AVD, which removes bleomycin, for the treatment of newly diagnosed advanced stage HL patients.

After completing a combination regimen of ADCETRIS plus AVD, 24 of 25 patients (96 percent) achieved a complete remission. Among the patients in the ADCETRIS plus ABVD cohorts, 21 of 22 patients (95 percent) who completed frontline therapy on study achieved a complete remission. The most common adverse events of any grade occurring in more than 30 percent of patients across both treatment regimens were hair loss, constipation, diarrhea, fatigue, insomnia, nausea, neutropenia, peripheral sensory neuropathy, fever and vomiting. As previously reported, pulmonary toxicity was seen in the ADCETRIS plus ABVD cohorts, resulting in a contraindication for the concomitant administration of ADCETRIS and bleomycin. No pulmonary toxicity was observed in the ADCETRIS plus AVD cohort.

These data support the enrollment of the ongoing global phase 3 ECHELON-1 trial. The design of the phase 3 trial will be described in a presentation at ISHL, titled Phase 3 Study of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine (A+AVD) vs Doxorubicin, Bleomycin, Vinblastine and Dacarbazine (ABVD) as Front-line Treatment for Advanced Classical Hodgkin Lymphoma (HL): The ECHELON-1 Study, (P017) by Dr. John Radford, Professor of Medical Oncology, University of Manchester. Visit http://www.clinicaltrials.org for more information about ECHELON-1.

Frontline HL Data Presentations: Investigator-sponsored Trials

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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Clinical Data in the Frontline Setting at the ...

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