Novartis Kisqali demonstrates nearly five years median overall survival in metastatic breast cancer

  • MONALEESA-7 median overall survival (OS) results reinforce Kisqali as the CDK4/6 inhibitor with unrivaled OS evidence1

  • Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up1

  • Kisqali offers the chance for more life for younger women with HR+/HER2- MBC, which remains the leading cause of cancer death in women 20-59 years old2,3

Basel, December 9, 2020 - Novartis today announced updated median overall survival (OS) results for Kisqali (ribociclib) in combination with endocrine therapy, marking the longest survival data ever reported in premenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+HER2-) metastatic breast cancer. The Phase III MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in preand perimenopausal women with HR+/HER2- metastatic breast cancer. These updated median OS data will be presented today at the 2020 San Antonio Breast Cancer Virtual Symposium.

After a median of 53.5 months follow-up, median OS for patients taking Kisqali in combination with endocrine therapy was 58.7 months vs. 48.0 months for endocrine therapy alone (HR=0.76 [95% CI: 0.61-0.96])1. Additionally, a similar median OS benefit of 58.7 months was observed with Kisqali plus an aromatase inhibitor subgroup vs. 47.7 months in the placebo plus aromatase inhibitor subgroup (HR=0.80 [95% CI, 0.62-1.04]), and the survival benefit shown in subgroup analyses was consistent with the intent-to-treat (ITT) population1. This exploratory ad hoc analysis follows the previously reported MONALEESA-7 OS analysis presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine, which demonstrated statistically significant OS results for Kisqali in combination with endocrine therapy. After a median of 42 months follow-up, the estimated survival rate was 70.2% [95% CI: 63.5 to 76.0] for women who received Kisqali in combination with endocrine therapy compared to 46.0% [95% CI, 32.0 to 58.9] for women who received endocrine therapy alone (HR=0.71 [95% CI: 0.54 to 0.95]) p=0.00973)4.

"These longer-term data showing ribociclib can help women with metastatic breast cancer live longer are remarkable and emphasize the progress we’ve made in treating this disease, which until now, had an estimated median survival of just three years," said Debu Tripathy, M.D., chair of Breast Medical Oncology, MD Anderson Cancer Center. "I’m hopeful the proven overall survival benefit with ribociclib will shift the standard for those with metastatic breast cancer, and that patients are empowered to ask their doctors about which treatments give them the best chance of living longer with the best quality of life."

The need for chemotherapy was delayed by more than four years (50.9 months) in patients taking Kisqali in combination with endocrine therapy (HR=0.69; 95% CI: 0.56-0.87)1. No new adverse events were observed. Kisqali is not indicated for use with tamoxifen.

"We’re proud to be able to provide the CDK4/6 inhibitor with the longest ever reported median overall survival benefit of nearly five years in younger women," said Susanne Schaffert, Ph.D., President, Novartis Oncology. "It is our vision to develop therapies that give patients the longest life possible, and these best-in-class data help us realize that vision by proving Kisqali extends the lives of younger premenopausal women with metastatic breast cancer, who typically have more aggressive disease and unique needs."

Metastatic breast cancer in premenopausal women is biologically distinct, more aggressive and the leading cause of cancer death in women 20-59 years old2,3.

About Kisqali (ribociclib)
Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Kisqali in combination with an aromatase inhibitor was approved for the treatment of pre-, perior postmenopausal women as initial endocrine based therapy, and also indicated for use in combination with fulvestrant as both firstor second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

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