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Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the initiation of a phase 2 clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with RCHOP (A+RCHOP), the current standard frontline therapy, for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL). The study is intended to evaluate the complete remission rate and safety of the A+RCHOP regimen. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS is currently not approved for the treatment of DLBCL.
“The encouraging data we have observed in our phase 2 trial of ADCETRIS in relapsed non-Hodgkin lymphoma, including DLBCL patients, support evaluation in earlier lines of therapy for patients with this aggressive lymphoma type,” said Clay B. Siegall., Ph.D., President and Chief Executive Officer at Seattle Genetics. “This trial will provide us with data on the tolerability of the combination, as well as the antitumor activity achieved by adding ADCETRIS to the current standard frontline regimen. In addition, based on interim findings from our trial in the relapsed setting in which objective responses were observed among patients with low or undetectable levels of CD30 by conventional screening methods, we will enroll high-risk DLBCL patients to this frontline trial without prescreening for CD30 expression.”
In this phase 2, open-label clinical trial, approximately 50 frontline high-risk DLBCL patients will receive ADCETRIS in combination with the standard of care consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (A+RCHOP). Patients will be randomized to receive standard dose RCHOP with either 1.2 milligrams per kilogram (mg/kg) or 1.8 mg/kg of ADCETRIS. The trial will enroll patients regardless of CD30 expression level by immunohistochemistry (IHC) to further explore previously reported interim data from an ongoing phase 2 trial for relapsed B-cell lymphomas, including DLBCL, demonstrating objective responses in patients with varying levels of CD30. The primary endpoints are to assess the complete remission rate and safety profile of the combination. Secondary endpoints include objective response rate, progression-free survival and overall survival.