Seattle Genetics and Takeda Pharmaceutical have completed patient enrolment for the Phase III ECHELON-2 clinical trial of ADCETRIS (brentuximab vedotin) to treat CD30-positive mature T-cell lymphoma (MTCL).
The Phase III double-blind, placebo-controlled Echelon-2 study is testing ADCETRIS with cyclophosphamide (C), doxorubicin (H) and prednisone (P) (A+CHP) against cyclophosphamide, doxorubicin, vincristine (O) and prednisone (CHOP) in 452 patients with previously untreated CD30-positive MTCL.
The patients were randomised to receive the combination therapy of A+CHP and CHOP.
Seattle Genetics clinical development vice-president Naomi Hunder said: “Our goal is to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas and redefine frontline treatment in Hodgkin lymphoma and MTCL through our broad, late-stage clinical development programme currently underway.
“The ECHELON-2 clinical trial represents our fourth phase III study to complete enrolment.”
Hunder added: “The ultimate goal of this phase III trial is to improve outcomes for frontline patients with CD30-expressing MTCL and, if the trial results are positive, to submit data from this trial to regulatory agencies to expand the label for ADCETRIS use in the frontline setting.”
ADCETRIS is an antibody-drug conjugate (ADC) consisting of an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology.
The ADC uses a linker system to release MMAE after being injected into the CD30-expressing tumour cells.