ADCETRIS Phase II trial to begin

The Phase II study of a new drug treatment for patients that have been newly diagnosed with diffuse large B-cell lymphoma has begun. The trial, being run by Seattle Genetics, is looking at the effects of ADCETRIS when used with the current go-to therapy, RCHOP. The Phase II trial will help to evaluate the complete remission rate following treatment.

ADCETRIS is not yet approved for the treatment of diffuse large B-cell lymphoma, but the trial will help to evaluate the safety of the drug when combined with the current standard front line treatment. In order to test the effects of the drug, an open-label trial involving 50 frontline high risk patients suffering from diffuse large B-cell lymphoma will soon begin. ADCETRIS has been designed to act as an antibody-drug conjugate. It is directed towards a patients CD30, a lymphoid activation gene.  

Each of the 50 patients will be given doses of ADCETRIS along with doses of RCHOP. Patients will receive the standard dose of RCHOP, but randomised patients will also be given either 1.2 or 1.8 milligrams per kilogram of ADCETRIS. Patients will be enrolled in the study regardless of their expression of CD30, in order to explore interim data that has been produced as part of another study looking at relapsed B-cell  lymphomas.

Doctor Clay B Siegall, the president and chief executive of Seattle Genetics, said: "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."

"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."