March 20, 2018
The Food and Drug Administration approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
Approval was based on a randomized, open-label, two-arm, multicenter trial, ECHELON-1, that randomized 1,334 patients to receive either Adcetris plus doxorubicin, vinblastine, and dacarbazine (Adcetris + AVD) or bleomycin plus AVD (ABVD). Patients were randomized to receive up to 6 cycles of Adcetris + AVD or ABVD on Days 1 and 15 of each 28-day cycle.
Efficacy was established based on modified progression-free survival (mPFS), defined as progression, death, or receipt of additional anticancer therapy for patients who are not in a complete response after completion of frontline therapy. The estimated median mPFS was not reached in either arm, with a median follow-up time of 24.6 months. There were 117 events (18%) on the Adcetris + AVD arm and 146 events (22%) on the ABVD arm (hazard ratio 0.77; 95% CI: 0.60, 0.98; p=0.035), corresponding to a 23 percent reduction in the risk of an mPFS event. At the time of the mPFS analysis, an interim overall survival analysis did not demonstrate a significant difference.