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Adcetris Data Positive in DLBCL

Ph II results lead to expanded trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Seattle Genetics has posted updated results from a Phase II clinical trial of Adcetris (brentuximab vedotin) in diffuse large B-cell lymphoma (DLBCL) and other B-cell non-Hodgkin lymphomas. The interim data demonstrated an encouraging activity and tolerability profile in the relapsed and refractory setting.

The results showed that single-agent Adcetris induced a 42% objective response rate and manageable safety profile among advanced DLBCL patients, including a high percentage whose disease was refractory to their prior therapy. Based on the results, the company has expanded its clinical program for Adcetris in DLBCL both as a single-agent and in combination with standard regimens for both relapsed and newly diagnosed patients.”

The data were presented in an oral presentation at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, LA. Adcetris is an antibody-drug conjugate (ADC) directed to CD30. Adcetris is currently not approved for the treatment of DLBCL or other B-cell lymphomas.

The phase II trial presented at ASH has been expanded to include a treatment arm to assess the activity and tolerability of Adcetris in combination with Rituxan (rituximab) as well as an arm to evaluate single-agent Adcetris in patients with undetectable CD30 expression using standard immunohistochemistry methods. In addition, a phase II trial was recently initiated to evaluate Adcetris plus R-CHOP in newly diagnosed, high-risk DLBCL patients, regardless of CD30 expression level.

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