Trial Initiated to Study Adcetris with R-CHOP in DLBCL Patients

Seattle Genetics has announced the launch of a phase II clinical trial evaluating Adcetris (brentuximab vedotin) in combination with R-CHOP (therefore called A+R-CHOP) for newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL).

About the trial

The trial will evaluate the complete remission rate and safety of the A+RCHOP regimen. Currently, Adcetris is not market approved to treat DLBCL.

R-CHOP remains the standard of care in the frontline treatment of DLBCL, a non-Hodgkin's lymphoma that is the most commonly diagnosed lymphoma subtype.

Clay B. Siegall, Ph.D., president and chief executive officer at Seattle Genetics said:

The encouraging data we have observed in our phase II trial of Adcetris in relapsed non-Hodgkin's lymphoma, including DLBCL patients, support evaluation in earlier lines of therapy for patients with this 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. 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.

Phase II

This phase II trial is designed as an open-label clinical trial that will recruit about 50 frontline high-risk DLBCL patients. They will receive Adcetris along with 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 to further explore previously reported data that shows some 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.

Source: WSJ