Seattle Genetics has commenced Phase II open-label trial of Adcetris (brentuximab vedotin), an antibody-drug conjugate (ADC) directed to CD30, along with the current standard frontline therapy Rchop (A+RCHOP) for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL).
The study will involve approximately 50 frontline high-risk DLBCL patients, who will be administered with Adcetris in combination with the standard of care consisting of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (A+RCHOP) to assess the complete remission rate and safety of the A+RCHOP regimen.
Seattle Genetics president and chief executive officer Dr Clay Siegall said the encouraging data in Phase II trial of Adcetris in relapsed non-Hodgkin lymphoma, including DLBCL patients, support evaluation in earlier lines of therapy for patients with the aggressive lymphoma type.
"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," Siegall added.
"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."
Patients will be randomised with standard dose RCHOP with either 1.2mg/kg or 1.8mg/kg of Adcetris.
In the study, patients, regardless of CD30 expression level by immunohistochemistry (IHC), will be enrolled to further explore previously reported interim data from an ongoing Phase II trial for relapsed B-cell lymphomas, including DLBCL, demonstrating objective responses in patients with varying levels of CD30.
The study's primary endpoints are the complete remission rate and safety profile of the combination, while secondary endpoints include objective response rate, progression-free survival and overall survival.
Image: Micrograph of a large B cell lymphoma. Photo: Nephron.