AstraZeneca has announced a NICE recommendation for two acalabrutinib-based combinations, expanding access to new first-line treatment options for eligible adults with mantle cell lymphoma (MCL) and chronic lymphocytic leukaemia (CLL) in England and Wales.
For CLL, they introduce the first and only all-oral fixed-duration regimen incorporating a second-generation BTK inhibitor, while for MCL they bring a targeted BTK inhibitor into the first-line treatment pathway for eligible patients.
Toby Eyre, Consultant Haematologist at Oxford University Hospitals NHS Foundation Trust, said: “This fixed-duration treatment option provides eligible patients with access to an innovative regimen that offers the flexibility of planned time off treatment.”
The NICE recommendation makes acalabrutinib plus venetoclax available as an all-oral, fixed-duration first-line treatment option with demonstrated efficacy for eligible patients with previously untreated CLL.
This recommendation is supported by results from the phase 3 AMPLIFY trial, in which acalabrutinib plus venetoclax reduced the risk of disease progression or death by 35% compared with standard-of-care chemoimmunotherapy. At three years after treatment initiation, 77% of patients treated with acalabrutinib plus venetoclax were progression-free, compared with 67% of patients receiving chemoimmunotherapy.
Dallas Pounds, Director of Services of Lymphoma Action, said: “A blood cancer diagnosis can have a significant impact on every aspect of a person’s life, so having access to a range of effective treatment options is incredibly important. These recommendations give eligible people with MCL greater choice, allowing treatment decisions to better reflect each person’s clinical needs, lifestyle and preferences.”
The NICE recommendation for MCL is supported by results from the phase 3 ECHO trial which met its primary endpoint, in which acalabrutinib plus bendamustine and rituximab significantly improved progression-free survival compared with placebo plus bendamustine and rituximab. Median progression-free survival was 66.4 months with the acalabrutinib combination compared with 49.6 months with placebo plus bendamustine and rituximab.
Tom Keith-Roach, Country President of AstraZeneca UK, said: “Every step that broadens access to innovation matters as we work towards our bold ambition of eliminating blood cancer as a cause of death. Together with the NHS, we remain focused on bringing meaningful advances to patients as quickly as possible.”