Swiss pharma giant Novartis’ Kisqali (ribociclib) succeeded in a phase 3 trial in combination with endocrine therapy as initial treatment in women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
The Kisqali combination therapy, which was evaluated in both pre- and perimenopausal women in the late-stage trial called MONALEESA-7, delivered statistically significant overall survival (OS) results in comparison to endocrine therapy alone.
Following a median of 42 months follow-up, the survival rate for women subjected to the investigational combination therapy was 70.2%, while it was 46.0% for women who were treated with only endocrine therapy.
The endocrine therapy used in the trial was a combination of goserelin with an aromatase inhibitor or tamoxifen.
Novartis Oncology CEO Susanne Schaffert said: “Kisqali is the only CDK4/6 inhibitor to achieve statistically significant overall survival benefit in combination with endocrine therapy, and we are so proud to share these powerful data with the medical and patient community.
“These exciting results add to the proven efficacy and safety profile of Kisqali, solidify it as a standard of care for people living with HR+/HER2- metastatic breast cancer and inspire us to continue to reimagine medicine.”
Kisqali has approval in more than 75 countries, including the US and European Union member states.
The CDK4/6 inhibitor in combination with an aromatase inhibitor was approved initially in March 2017 by the US Food and Drug Administration (FDA) as initial endocrine-based therapy for HR+/HER2- locally advanced or metastatic breast cancer in postmenopausal women. In August 2017, the European Commission (EC) approved the combination for the same indication.
In July 2018, the Novartis drug in combination with an aromatase inhibitor was approved by the FDA as initial endocrine based therapy for the treatment of pre-, peri- or postmenopausal women. It was also indicated for use in combination with fulvestrant as first- or second-line therapy in postmenopausal women.
The EC followed suit in December 2018 by expanding the indication of the CDK4/6 inhibitor.
Novartis is evaluating Kisqali in early breast cancer as well. A phase 3 trial called NATALEE is investigating the drug in combination with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer.