Takeda's Adcetris (brentuximab vedotin) has won the backing of the National Institute for Health and Care Excellence (NICE) as a treatment for untreated systemic anaplastic large cell lymphoma (sALCL), a rare type of lymphoma.
The decision allows NHS funding for the drug alongside cyclophosphamide, doxorubicin and prednisone (CHP), giving patients access to the first new front-line treatment option for the condition in several decades.
To date, frontline treatment for newly diagnosed sALCL patients has typically been multi-agent chemotherapy, such as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), which is generally associated with poor outcomes, with many patients failing to achieve long-term survival, the firm notes.
In the clinical trial ECHELON-2, Adcetris plus CHP demonstrated superior progression-free survival and overall survival versus CHOP in the sALCL patient population, which corresponded to a 41% reduction in the risk of a progression event and a 46% reduction in the risk of death.
Adcetris in combination with CHP also demonstrated versus CHOP: a higher rate of objective response (88% vs. 71%); a higher rate of complete response (71% vs 53%); and a comparable safety profile, with a similar incidence of peripheral neuropathy (52% vs 55%) and febrile neutropenia (18% vs 15%).
“The data seen in this large Phase III randomised trial with brentuximab vedotin plus CHP in the untreated sALCL patient population is practice changing and has the potential to significantly improve the chance of survival for patients. This is the first large randomised study in T cell lymphoma to show real clinical benefits, providing new hope for patients fighting this aggressive disease,” commented Tim Illidge, Professor of Targeted Therapy and Oncology at The Christie NHS Foundation Trust.
“Brentuximab vedotin is a medicine that continues to innovate and transform the treatment paradigm for patients with rare types of lymphoma,” added Jon Neal, managing director, Takeda UK & Ireland. “We are committed to working in partnership with the clinical and patient community, and NICE and NHS England, to ensure as many eligible patients can benefit from access to this medicine as possible.”
Adcetris is already available as a monotherapy for adult patients with relapsed/refractory sALCL in England, Wales and Northern Ireland after failure of at least one chemotherapy agent.