Seattle Genetics, Takeda Achieve Target Enrollment In Phase 3 ECHELON-1 Trial

(RTTNews) - Seattle Genetics, Inc. (SGEN) and Takeda Pharmaceutical Company Limited said the companies have achieved completion of target patient enrollment in the phase 3 ECHELON-1 clinical trial.

ECHELON-1 is a randomized trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced classical Hodgkin lymphoma or HL.

ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for the frontline treatment of HL.

Patients in ECHELON-1 were randomized to receive either ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a recognized standard of care for frontline HL, or a novel combination consisting of ADCETRIS+AVD, which removes bleomycin from the regimen.

The trial has enrolled approximately 1,300 patients. It remains open at select sites to complete enrollment of approximately 20 patients in an additional cohort to fulfill an ex-U.S. regulatory commitment related to measurement of drug levels during treatment (pharmacokinetics).

The ECHELON-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration and the trial also received European Medicines Agency scientific advice.