Adcetris meets in Phase III for first-line PTCL

Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said Adcetris brentuximab vedotin plus chemotherapy met the primary and all key secondary endpoints in the Phase III ECHELON-2 trial to treat previously untreated CD30-expressing peripheral T cell lymphoma (PTCL). The partners will present the data at the American Society of Hematology (ASH) meeting in San Diego in December, and plan to submit global regulatory applications for Adcetris in the indication, including an sBLA to FDA in the near future.

On ECHELON-2's primary endpoint, Adcetris plus cyclophosphamide, doxorubicin and prednisone (CHP) chemotherapy significantly improved progression-free survival (PFS) vs. cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy (HR=0.71, p=0.011). Adcetris plus CHP also met the secondary endpoints of improving overall survival (OS) (HR=0.66, p=0.0244), PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate and objective response rate vs. CHOP. The double-blind, international trial enrolled 452 patients, of which about 75% had sALCL. The partners have an SPA from FDA for the trial and have received scientific advice from EMA...