Novartis announces updated median overall survival (OS) data from phase III MONALEESA-3 trial of CDK4/6 inhibitor ribociclib in combination with fulvestrant in postmenopausal women with HR+/HER2- metastatic breast cancer

Exploratory analysis found that with extended follow-up of >4 years, the combination continued to demonstrate an OS benefit of 53.7 months vs. 41.5 months for fulvestrant alone (HR=0.73; 95% CI: 0.59-0.90 after additional 16.9 months of follow-up)

SPS commentary:

NICE guidance recommends ribociclib plus fulvestrant for hormone +ve, HER2-ve, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy only if exemestane plus everolimus is the most appropriate alternative to a CDK 4/6 inhibitor.

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Resource links:

NICE guidance