Novartis Kisquali (ribociclib) has shown superior overall survival compared to AstraZeneca’s fulvestrant (Faslodex) in certain breast cancer patients.
In the MONALEESA-3 trial, published in The New England Journal of Medicine (NEJM), Kisqali plus fulvestrant demonstrated a statistically significant improvement in overall survival, with an almost 30% reduction in risk of death compared to the latter alone, in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
At 42 months, estimated survival rates among patients who received first-line therapy were 66.9% with Kisqali plus fulvestrant vs. 56.3% with fulvestrant alone.
Median overall survival among patients in the early-relapse and second-line subgroup was 40.2 months with Kisqali plus fulvestrant and 32.5 months with fulvestrant alone.
Also, a new post-hoc overall survival analysis based on prior endocrine therapy demonstrated that Kisqali plus fulvestrant had a: 36% reduction in risk of death endocrine therapy-naiive patients; a 30% reduction in risk of death in those who were endocrine resistant; and a 26% reduction in risk of death in those who were endocrine sensitive.
“These data show that treatment with Kisqali gives women with HR+/HER2- advanced breast cancer a chance for more life – whether they are treatment naïve or have had prior therapy,” said Jeff Engelman, global head of Oncology Research, Novartis Institutes for BioMedical Research. “Preclinical data show that Kisqali is distinct from other CDK4/6 inhibitors in its ability to more selectively target and inhibit CDK4.”