Novartis has announced that its breast cancer drug, Kisqali (ribociclib), has achieved statistically significant improvement in overall survival in the Phase III MONALEESA-3 clinical trial.
The success marks the second Phase III clinical trial in which the Kisqali combination therapy met the key secondary endpoint of overall survival at the pre-planned interim analysis.
MONALEESA-3 evaluated efficacy and safety of the drug with 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.
The company 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, president of Novartis Oncology.
She continued, “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.
The news comes shortly after The National Institute of Health and Care Excellence (NICE) made a u-turn on its decision to reject the drug, and recommended it for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative.