Novartis at ESMO: Kisqali plus fulvestrant achieved statistically significant overall survival benefit vs. fulvestrant alone in postmenopausal women

Novartis will present results from its trial designated Mnaleesa-3, which showed that ribociclib branded as Kisqali has achieved statistically significant improvement in overall survival (OS), which is – according to Novartis – the only CDK4/6 inhibitor to demonstrate positive overall survival in two pivotal Phase III trials — consistently demonstrating approximately 30% reduction in the risk of death.

Novartis pointed out in its press release Sunday that this is the second Phase III trial in which Kisqali combination therapy met the secondary endpoint of overall survival at the pre-planned interim analysis.

Kisqali in combination with fulvestrant met its secondary endpoint of overall survival, demonstrating a statistically significant improvement in survival with a 28% reduction in risk of death, Novartis said. Furthermore, at 42 months, estimated rates of survival were 58% for Kisqali combination treatment and 46% for fulvestrant alone.

“The remarkable results from MONALEESA-3 and MONALEESA-7 make Kisqali the CDK4/6 inhibitor with consistently superior overall survival,” said Susanne Schaffert, President, Novartis Oncology. She said that in nearly 25 years, the five-year survival rates in HR+ metastatic breast cancer have improved by less than 5%.

Jeff Engelman, Global Head of Oncology Research, Novartis Institutes for BioMedical Research said that pre-clinical data show that Kisqali is distinct from other CDK4/6 inhibitors in its ability to more selectively target and inhibit CDK4. He said that CDK4 is a major driver of breast cancer progression and inhibiting it has been shown to block the growth of breast cancer cells.