Seattle Genetics, Inc. (Nasdaq:SGEN) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients. The data were presented at the 54 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for use in the front-line treatment of HL.
In the phase I trial, newly diagnosed patients received ADCETRIS concomitantly with either ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or AVD, which removes bleomycin from the regimen. At the end of front-line therapy, 24 of 25 patients (96 percent) treated with ADCETRIS plus AVD and 21 of 22 (95 percent) patients treated with ADCETRIS plus ABVD had a complete remission. None of the patients treated in the ADCETRIS plus AVD cohort experienced pulmonary toxicity, compared with an expected rate of pulmonary toxicity caused by ABVD alone of 10-25 percent. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed as a secondary endpoint.
"For over 30 years, the standard of care for front-line HL has been a chemotherapy regimen called ABVD that has demonstrated a complete remission rate of 70 to 80 percent and is associated with considerable life-threatening toxicities. There is a significant need to identify better treatment options for patients in the front-line HL setting,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "Our goal is to redefine front-line treatment of HL with the addition of ADCETRIS, and the encouraging results of this phase I trial clearly support this goal and provide rationale for the ongoing ADCETRIS phase III trial in this setting."