NICE has recommended abemaciclib (Verzenios) with an aromatase inhibitor as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults.
The decision is based on data from the double-blind, placebo-controlled, randomised MONARCH 3 trial comparing letrozole or anastrozole in combination with abemaciclib or placebo.
In the final independent review, median progression-free survival was not reached for abemaciclib and was 19.36 months for placebo (HR 0.465; 95% CI 0.339-0.636).
The overall survival data from MONARCH 3 are immature. At the final progression-free survival analysis (93 deaths were observed across the 2 groups), overall survival was similar between the treatment groups (HR 1.057; 95% CI 0.683-1.633).
The NICE recommended dosing regimen for abemaciclib is 150 mg orally, twice daily, alongside an aromatase inhibitor. Treatment should be continued as long as the patient is having clinical benefit or until unacceptable toxicity occurs.
The shelf cost of the treatment is £2950 for 56x150 mg tablets (excluding VAT). However, NICE says that, taking into account the commercial arrangements for all the cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors 4/6 inhibitors, abemaciclib is a cost-effective use of NHS resources.
In pre- or perimenopausal women, treatment should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.