Phase III ECHELON-1 trial of Adcetris (brentuximab vedotin) met primary endpoint in untreated Hodgkin lymphoma- Takeda Pharmaceutical and Seattle Genetics

Takeda Pharmaceutical and Seattle Genetics announced that the Phase III ECHELON-1 clinical trial of Adcetris (brentuximab vedotin) in previously untreated advanced classical Hodgkin lymphoma met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) versus the control arm. ECHELON-1 is a randomized, multicenter trial evaluating brentuximab vedotin as part of a frontline combination chemotherapy regimen in 1,334 patients with previously untreated advanced classical Hodgkin lymphoma.

Patients in ECHELON-1 were randomized to receive either a combination of Adcetris +AVD (Adriamycin, vinblastine, dacarbazine) or ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine), a recognized standard of care for frontline Hodgkin lymphoma. The results of the ECHELON-1 trial demonstrated that combination treatment with Adcetris resulted in a statistically significant improvement in modified PFS versus the control arm as assessed by an Independent Review Facility. The two-year modified PFS rate for patients in the Adcetris arm was 82.1 percent compared to 77.2 percent in the control arm. Interim analysis of overall survival (OS), the key secondary endpoint, also trended in favor of the Adcetris +AVD arm.

The safety profile of Adcetris +AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen. There was an increased incidence of febrile neutropenia and peripheral neuropathy in the Adcetris +AVD arm. Febrile neutropenia was reduced through the use of prophylactic growth factors in a subset of patients, and peripheral neuropathy was managed through dose modifications. The control arm had an increased rate and severity of pulmonary toxicity. An abstract will be submitted for data presentation at the American Society of Hematology (ASH) annual meeting.