Phase III ECHELON-2 trial of Adcetris meets primary endpoint in T-cell lymphoma.- Seattle Genetics + Takeda

Seattle Genetics and Takeda announced that the phase III ECHELON-2 clinical trial of Adcetris (brentuximab vedotin) in patients with previously untreated CD30-expressing peripheral T-cell lymphoma met its primary endpoint. The trial demonstrated a statistically significant improvement in progression-free survival (PFS) of Adcetris (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control arm, CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). ECHELON-2 is a global, randomized, double-blind, multicenter trial evaluating Adcetris as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), also known as mature T-cell lymphoma (MTCL). Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of several types of PTCL. Adcetris is currently not approved for the frontline treatment of PTCL.

Results from the trial demonstrated that combination treatment with Adcetris plus CHP was superior to the control arm for PFS as assessed by an Independent Review Facility (IRF; hazard ratio=0.71; p-value=0.0110). The Adcetris plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; p-value=0.0244). All other key secondary endpoints, including PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate were statistically significant in favor of the ADCETRIS plus CHP arm. The safety profile of Adcetris plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of Adcetris in combination with chemotherapy. Additional data will be presented at the American Society of Hematology (ASH) 2018 annual meeting.

Comment: These data show a significant improvement in the primary endpoint of progression-free survival and all key secondary endpoints, including overall survival, along with a manageable safety profile. Takeda and Seattle Genetics plan to submit these results to regulatory authorities for approval in their respective territories.