NICE has issued draft guidance recommending abemaciclib with an aromatase inhibitor as first endocrine-based therapy for previously untreated, hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer.
The recommendation is based on data from the double blind, placebo-controlled, randomised MONARCH 3 trial comparing abemaciclib with placebo (both taken with letrozole or anastrozole). Interim results showed that median progression-free survival (PFS) was not reached for abemaciclib and was 19.2 months for placebo (HR 0.51; 95% CI 0.36-0.72). The final progression-free survival analysis was presented to the committee, but the results are confidential until publication.
The overall-survival (OS) data from MONARCH 3 are immature. At the interim analysis, OS was similar between the treatment groups (9.8% with abemaciclib and 10.3% with placebo).
Network meta-analyses carried out by the company compared abemaciclib with palbociclib and ribociclib (each with an aromatase inhibitor). Analyses included PFS, OS, and a number of response rates analyses, but networks were not possible for adverse events, treatment duration, and quality of life. The results of the meta-analysis are confidential but the NICE appraisal committee said similar treatment effects were shown for all 3 cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors.
“Taking into account the commercial arrangements for all cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors, abemaciclib is a cost-effective use of NHS resources and it can be recommended,” the guidance states.
A final decision is due from NICE later this month.