Seattle Genetics and Takeda have reported positive topline results from the Phase II ECHELON-2 trial investigating adcetris (brentuximab vedotin) as a frontline combination chemotherapy regimen to treat patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL).
Adcetris is being jointly developed by Seattle Genetics and Takeda as an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of various types of PTCL.
The trial’s primary endpoint was met when results showed that adcetris in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) was effective in increasing progression-free survival (PFS) and overall survival (OS).
Key secondary endpoints included PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission (CR) rate, and objective response rate (ORR).
The combination demonstrated a safety profile comparable to cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), an existing standard of care given to patients with CD30-expressing PTCL.
Common treatment-related adverse events reported during the trial were nausea, peripheral sensory neuropathy, neutropenia, diarrhea, and constipation.
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Takeda Oncology Clinical Research and Development vice-president and head Jesús Gómez-Navarro said: “The study demonstrated clinically meaningful outcomes and was the first randomised Phase III trial in frontline PTCL to show improvement in overall survival.
“Establishing an optimal therapy for PTCL has been a challenge for physicians, and these findings represent the progress in addressing the unmet needs of people living with this serious disease.”
ECHELON-2 followed a global, randomised, double-blind, multi-center trial design.
It enrolled a total of 452 patients at 132 sites in 17 countries across North America, Europe, Asia Pacific and the Middle East.
Most patients had sALCL and 80% suffered from advanced disease.