Health Canada has expanded its approval of Adcetris (brentuximab vedotin) in combination with a chemotherapy regimen for the first-line treatment of peripheral T-cell lymphomas expressing the CD30 marker.
The approval is for Adcetris in combination with CHP (cyclophosphamide, doxorubicin, prednisone) chemotherapy, and is for people with previously untreated systemic anaplastic large cell lymphoma (sALCL), peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), or angioimmunoblastic T-cell lymphoma (AITL).
It was based on data from the ECHELON-2 Phase 3 trial (NCT01777152), where the combination extended survival outcomes and increased complete response rates with a similar safety profile as standard CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
The trial results “demonstrated Adcetris (brentuximab vedotin) plus CHP regimen was superior for both progression-free survival and all key secondary endpoints, including overall survival, when compared to the standard of care CHOP chemotherapy,” Kerry Savage, MD, a professor at the University of British Columbia and investigator on the ECHELON-2 trial, said in a press release.
The approval represents “the first major advance for Canadian patients with PTCL in decades,” she added.
ECHELON-2 included 452 patients with newly diagnosed PTCL whose tumors were positive for the CD30 factor. Of them, 75% had sALCL. The trial’s main goal was to determine whether Adcetris add-on treatment could extend the time to disease progression or death compared to standard CHOP chemotherapy.
The combination lowered the risk of disease progression or death by 29%, and the risk of death from any cause by 34%, compared to CHOP chemotherapy alone. It also reduced tumor burden in a larger proportion of patients (83%) than CHOP (72%). Complete responses, or the elimination of all traces of cancer, was also more common with the Adcetris combo (68% vs. 56% with CHOP).
“ECHELON-2 is the first randomized trial to demonstrate an overall survival benefit over established standard therapy, making it a meaningful advance in the treatment of these rare lymphomas,” said Roger Dansey, MD, chief medical officer at Seattle Genetics, which developed Adcetris. “With this new indication for Adcetris, physicians and eligible patients in Canada now have access to this important new regimen for treating frontline CD30-expressing peripheral T-cell lymphoma.”
Adcetris is an antibody that has been engineered to carry a toxic drug. The antibody specifically binds to CD30, a protein marker expressed by many lymphoma cells. Once bound to CD30-positive cells, the toxic payload is released, killing the cells.
The treatment is approved in Canada for many lymphoma types, including in combination with standard chemotherapy as a frontline therapy for advanced classical Hodgkin’s lymphoma, an approval that came in May this year based on data from the ECHELON-1 Phase 3 trial (NCT01712490).