Novartis’ CDK4/6 Inhibitor Kisqali Reports Longest Median Overall Survival of 63.9 Months in HR+/HER2- Advanced Breast Cancer
Mar 22, 2022 02:27
CST Updated
02:27
Novartis
Drug Development and Manufacturing
News on March 21, 2022 /BioValleyBIOON/ --Novartis(Novartis) recently announced that the International Medical Journal "New England Journal of Medicine (NEJM)" published the targeted anticancer drug CDK4/6 inhibitor Kisqali (ribociclib) treatmentBreast CancerData from the Phase 3 MONALEESA-2 trial showed: with a median follow-up of 80 months, in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, Kisqali plus letrozole significantly improved overall survival (OS) compared to letrozole alone, with statistically significant results.Median OS was extended by more than 12 months (63.9 months vs 51.4 months).; HR=0.76 [95% CI: 0.63-0.93]; two-sided p=0.008).
These data show the longest median overall survival (OS) benefit ever reported for patients with HR+/HER2- advanced breast cancer, supporting the use of Kisqali combination therapy as a first-line treatment.
Gabriel N. Hortobagyi, M.D., of The University of Texas MD Anderson Cancer Center, stated: "These positive overall survival data from the MONALEESA-2 trial represent a significant advancement in extending the lives of patients with advanced breast cancer. Achieving overall survival isClinical TrialThe gold standard, particularly impressive in first-line treatment. Despite more patients in the placebo group subsequently receiving CDK4/6 inhibitor therapy, the Kisqali treatment group demonstrated a statistically significant overall survival benefit for over a year. The newly released data further solidify Kisqali combined with letrozole as the preferred CDK4/6 inhibitor combination, extending the survival time for postmenopausal women with HR+/HER2- advanced breast cancer.
Data published in the NEJM are as follows: (1) The median overall survival of patients in the Kisqali + letrozole group exceeded five years (63.9 months), compared to four years (51.4 months) in the letrozole alone group (HR=0.76; 95% CI: 0.63-0.93; two-sided p=0.008). (2) Compared with patients receiving letrozole monotherapy, those receiving Kisqali + letrozole as first-line treatment had a 24% reduction in the risk of death.(3) Does the overall survival benefit of Kisqali + letrozole continue to increase over time? The 5-year survival rate for patients receiving Kisqali + letrozole was 52.3% (8.4% higher than letrozole alone), and the 6-year survival rate was 44.2% (12.2% higher than letrozole alone).(4) Fewer patients in the Kisqali + letrozole group received any subsequent CDK4/6 inhibitor treatment (34.4% in the letrozole group vs. 21.7% in the Kisqali + letrozole group); the significant overall survival benefit of Kisqali + letrozole was consistent after adjusting for any subsequent CDK4/6 inhibitor treatment. (5) Compared with patients treated with letrozole alone, those treated with Kisqali + letrozole experienced a one-year delay in the time to subsequent chemotherapy (50.6 months vs. 38.9 months).
This study is the CDK4/6 inhibitor reported to dateClinical TrialThe study with the longest follow-up period in China had a median follow-up time of 80 months, with no new safety signals reported; adverse events were consistent with the previously reported results of Kisqali's Phase 3 trials.
According to these results, the NCCN guidelines confirm that Kisqali is the only CDK4/6 inhibitor with OS benefits in first-line HR+/HER2- advanced breast cancer (aBC). Kisqali is the only CDK4/6 inhibitor that has consistently demonstrated OS benefits across all three Phase 3 trials, regardless of menopausal status, metastatic sites and numbers, prior treatments, concomitant endocrine therapy, or treatment lines.
NovartisTumorPresident Susanne Schaffer, PhD, stated: "The most compelling aspect of these MONALEESA-2 study data is seeing the overall survival benefit of Kisqali + letrozole improve over time for patients, regardless of disease characteristics. These meaningful results are raising the standard of care for patients with advanced breast cancer, who now have hope for a higher quality of life. The data continue to show that Kisqali is distinct from other CDK4/6 inhibitors, and we look forward to continuing to explore all its potential benefits for patients with HR+/HER2- breast cancer."(Bioon.com)