Novartis Kisqali reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients.

The analysis found that with extended follow-up of more than four years, Kisqali in combination with fulvestrant continued to demonstrate a clinically relevant OS benefit of more than a year compared with fulvestrant alone. These updated median OS data (Abstract #1001) will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. “Successfully demonstrating overall survival improvements in an incurable disease like metastatic breast cancer is a significant achievement, and is what we ultimately strive for in most clinical trials,” said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center. “When the MONALEESA-7 trial achieved median OS of nearly five years at SABCS 2020, it was the first time we saw a median survival this long with a CDK4/6 inhibitor in the metastatic setting. It is encouraging to see median OS results of nearly 4.5 years in the MONALEESA-3 study, underscoring that ribociclib offers hope for patients to have a longer life while preserving quality of life.” After a median follow-up of 56.3 months, median OS for patients taking Kisqali in combination with fulvestrant was 53.7 months vs. 41.5 months for fulvestrant alone (HR=0.73; 95% CI: 0.59-0.90)1. Additionally, Kisqali plus fulvestrant had prolonged OS in the first-line (median, not reached vs. 51.8 months; HR=0.64; 95% CI: 0.46-0.88) and second-line (median, 39.7 vs. 33.7 months; HR=0.78; 95% CI: 0.59-1.04) treatment subgroups. This exploratory ad hoc analysis follows the previously reported MONALEESA-3 OS analysis presented at the European Society of Medical Oncology (ESMO) Congress 2019 and published in the New England Journal of Medicine, which demonstrated statistically significant OS results for Kisqali in combination with fulvestrant with a 28% reduction in the risk of death (HR=0.72; 95% CI: 0.568-0.924; p=0.00455). Results from the subgroup analyses were consistent with the survival data seen with the intent-to-treat (ITT) population The need for chemotherapy was delayed to 4 years (48.1 months) in patients taking Kisqali in combination with fulvestrant and 28.8 months in the patients taking fulvestrant alone (HR=0.70; 95% CI: 0.57-0.88). Adverse events were consistent with previously reported Phase III trial results See- Slamon D, Neven P, Chia S, et al. "Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2? advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB.) " Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 5, 2021, (Abstract #1001). See-Tripathy D, Im S-A, Colleoni M, et al. "Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2? advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib ". Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Abstract #PD2-04.