Novartis Kisqali significantly prolongs life in women with HR+/HER2- advanced breast cancer now in two distinct Phase III trials

Novartis announced Kisqali (ribociclib) achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial. This is the second Phase III clinical trial in which Kisqali combination therapy met the key secondary endpoint of overall survival at the pre-planned interim analysis. MONALEESA-3 evaluated efficacy and safety of Kisqali plus fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in both the first-line and second-line settings.

“We are thrilled that Kisqali combination therapy again has demonstrated improved overall survival for patients with HR+/HER2- advanced breast cancer – first in pre-menopausal and peri-menopausal women in MONALEESA-7, and now in post-menopausal women in MONALEESA-3,” said Susanne Schaffert, PhD, President, Novartis Oncology. “We will continue to reimagine cancer to help patients live longer, and also improve quality of life as we work towards finding a cure for this incurable disease.”

No new safety signals were observed; adverse events were consistent with previously reported Phase III trial results. Kisqali is approved for use in various indications in more than 75 countries around the world.

Novartis will present the full results at an upcoming medical congress and submit the data to global health authorities.