Europe’s CHMP Recommends Approval of Brentuximab Vedotin in Hodgkin Lymphoma

Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended brentuximab vedotin for use as consolidation therapy following autologous hematopoietic cell transplantation (AHCT) in patients with relapsed/refractory CD30-positive Hodgkin lymphoma.

The CHMP recommendation is based on the results of the phase III AETHERA study, which included 329 patients who were randomized to receive 1.8 mg/kg of brentuximab vedotin administered intravenously every three weeks for a median of 15 cycles (n=165) or placebo (n=164). The median patient age was 32 years, and the median number of prior therapies was two (range = 2-8 therapies), with 47 percent of patient receiving >2 prior therapies.

Brentuximab vedotin reduced disease progression by 43 percent compared with placebo. The median progression-free survival (PFS; primary endpoint) was 42.9 months with brentuximab vedotin compared with 24.1 months with placebo (hazard ratio = 0.57; 95% CI 0.40-0.81; p=0.0013). The two-year PFS rate was 54 percent for those treated with brentuximab vedotin.

The estimated two-year overall survival (secondary endpoint) was 88 percent for both brentuximab vedotin and placebo, though this outcome was potentially confounded by the study’s crossover design, as 85 percent of patients in the placebo arm crossed over to received brentuximab vedotin.

The most common all-grade adverse events occurring in those receiving brentuximab vedotin and placebo included peripheral sensory neuropathy (56% and 16%, respectively) and neutropenia (35% and 12%). Most patients (85%) who received peripheral neuropathy while taking brentuximab vedotin had resolution within a median of 23.4 months. The primary cause of treatment discontinuation was disease progression.

Source: Takeda press release, May 27, 2016.

SHARE