Seattle Genetics Inc. (SGEN) 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 or DLBCL.
The study is intended to evaluate the complete remission rate and safety of the A+RCHOP regimen. Adcetris is an antibody-drug conjugate or ADC directed to CD30. Adcetris is currently not approved for the treatment of DLBCL.
According to the company, 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 company noted that the trial will enroll patients regardless of CD30 expression level by immunohistochemistry or 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.
by RTT Staff Writer
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