Novartis recently reported results from the MONALEESA-3 trial, the largest to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726), which showed that CDK4/6 inhibitor Kisqali (ribociclib) demonstrated statistically significant improvement in overall survival (OS).
Kisqali, in combination with fulvestrant, met its secondary endpoint of overall survival, revealing a 28-percent reduction in risk of death.
“At 42 months, estimated rates of survival were 58 percent for Kisqali combination treatment and 46 percent for fulvestrant alone," according to Novartis' press release. "Results in the first-line and second-line subgroups, including in patients who relapsed within 12 months of adjuvant treatment, were consistent with the overall MONALEESA-3 patient population. Median PFS in the first-line was also reached at this analysis and demonstrated that Kisqali, in combination with fulvestrant, has a median PFS of 33.6 months compared to 19.2 months in the placebo arm. Additionally, the need for chemotherapy was delayed in all patients who were prescribed Kisqali plus fulvestrant.”
The trial population was comprised of women with no previous endocrine therapy, including those diagnosed de novo, women who relapsed within 12 months of adjuvant therapy, and women who progressed on endocrine therapy for advanced disease.
“Seen now in two Phase III trials, ribociclib consistently and significantly prolongs life among premenopausal and postmenopausal women, and in combination with an aromatase inhibitor and fulvestrant," Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center, said in the press release. "These results arm oncologists with more evidence to make a confident treatment choice for their hormone receptor-positive metastatic breast cancer patients.”
The data was presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.