Kisqali + endocrine therapy demonstrates nearly five years median overall survival in metastatic HER2- breast cancer.- Novartis

— Novartis 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 pre- and perimenopausal women with HR+/HER2- metastatic breast cancer. These updated median OS data will be presented 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]). 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) population. 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) . 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. Metastatic breast cancer in premenopausal women is biologically distinct, more aggressive and the leading cause of cancer death in women 20-59 years old.