Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Clinical Data at International Conference on Malignant …

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

Seattle Genetics, Inc. (SGEN) today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 12th International Conference on Malignant Lymphoma (ICML) being held June 19-22, 2013 in Lugano, Switzerland. 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), that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and relapsed or refractory sALCL. Four oral and two poster presentations at ICML illustrated the broad clinical development program for ADCETRIS, including oral presentations describing the ongoing global phase 3 ECHELON-2 trial in frontline mature T-cell lymphoma (MTCL) and data from a phase 2 trial in patients with relapsed MTCL. In addition, an oral presentation included the first report of data from an investigator-sponsored trial evaluating ADCETRIS in first-relapse HL patients as part of a pre-autologous stem cell transplant regimen.

With last years European conditional marketing authorization supporting the use of ADCETRIS as a treatment for patients with relapsed HL and sALCL, this meeting provides us with an opportunity to share important ADCETRIS data with the international physician and patient community as we evaluate ADCETRIS in additional disease settings, said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. ADCETRIS is being evaluated for the treatment of CD30-positive malignancies in more than 20 ongoing clinical trials, including three global phase 3 trials. We look forward to the ongoing presentation of important data at medical meetings such as ICML, demonstrating the broad therapeutic potential of ADCETRIS.

Oral Presentations

PET-adapted Sequential Therapy with Brentuximab Vedotin and Augmented-ICE in Relapsed and Refractory Hodgkin Lymphoma (Abstract #141, oral session on Saturday, June 22, 2013 at 8:50 AM CET)

In an ongoing investigator-sponsored phase 2 clinical trial, patients with relapsed or refractory HL have been enrolled to determine whether ADCETRIS can replace the combination chemotherapy regimen ifosfamide, carboplatin and etoposide (ICE) or be used in sequential administration with ICE to increase the rate of pre-transplant FDG-PET normalization (PET-N), which is an important prognostic factor for patients undergoing autologous stem cell transplant (ASCT). At the time of data analysis, 40 patients had been enrolled and 33 patients had completed the treatment program. Key findings presented by Dr. Alison Moskowitz from Memorial Sloan Kettering Cancer Center include:

ADCETRIS is not approved for salvage HL patients who are deemed eligible for ASCT.

Safety and Efficacy of Brentuximab Vedotin for the Treatment of Relapsed Mature T-/NK-Cell Lymphomas (Abstract #152, oral session on Saturday, June 22, 2013 at 10:00 AM CET)

In an encore presentation from the 2012 American Society of Hematology (ASH) Annual Meeting, data were highlighted from a subset of patients in an ongoing phase 2 clinical trial evaluating ADCETRIS in CD30-positive non-Hodgkin lymphoma. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. At the time of data analysis, 29 patients with MTCL had been enrolled, including 11 with angioimmunoblastic T-cell lymphoma (AITL) and 18 with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS). The median number of prior systemic therapies in both lymphoma classifications was two. Key findings include:

ADCETRIS is not approved for the treatment of the MTCL subtypes described in this presentation.

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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Clinical Data at International Conference on Malignant ...