The FDA granted Breakthrough Therapy Designation to brentuximab vedotin in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
The positive topline results of the phase III ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the upcoming American Society of Hematology annual meeting, held Dec. 9-12.
The study evaluated a combination of brentuximab vedotin plus AVD (doxorubicin, vinblastine, dacarbazine) compared to a recognized standard-of-care chemotherapy regimen in previously untreated advanced classical Hodgkin lymphoma. The trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the brentuximab vedotin containing regimen versus the control arm as assessed by an Independent Review Facility (HR=0.770; p value=0.035).
The 2-year modified PFS rate for patients in the brentuximab vedotin arm was 82.1 percent compared to 77.2 percent in the control arm. Interim analysis of overall survival, the key secondary endpoint, also trended in favor of the brentuximab vedotin plus AVD arm. The safety profile of brentuximab vedotin plus AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen