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Updated trial results showed that the use of Kisqali plus fulvestrant was associated with an approximate 33% decrease in risk of death for women with HR-positive, HER2-negative advanced breast cancer.
Frontline treatment with Kisqali (ribociclib) plus fulvestrant added an average of nearly 16 months of survival benefit compared to fulvestrant alone in patients with HR-positive, HER2-negative advanced or metastatic breast cancer, according to updated findings from the phase 3 MONALEESA-3 clinical trial.
“MONALEESA-3 results continue to demonstrate the survival benefit of treatment with (Kisqali) for postmenopausal women with advanced breast cancer,” said Dr. Dennis J. Slamon, director of Clinical/Translational Research at University of California, Los Angeles Jonsson Comprehensive Cancer Center, in a press release. “Whether partnered with fulvestrant or an aromatase inhibitor in the first-line setting, (Kisqali) offers oncologists a CDK4/6 inhibitor with consistent benefit in providing women with HR-positive/HER2-negative advanced breast cancer more quality time, regardless of their disease characteristics.”
Kisqali works by blocking CDK4/6, the mechanism by which cells grow and multiply. According to National Comprehensive Cancer Network guidelines, Kisqali is the only CDK4/6 inhibitor that demonstrated an overall survival benefit in the frontline treatment of patients with HR-positive, HER2-negative advanced breast cancer.
The researchers conducted more than two-and-a-half years of additional follow up MONALEESA-3 since data was last presented in 2019. At the time of original data publication, Kisqali plus fulvestrant led to a 28% relative reduction in the risk of death compared to fulvestrant alone. Now, more updated data showed a 33% relative reduction in death risk.
The new data also showed that the combination led to improved overall survival (the time from treatment to death of any cause), with average overall survival being 67.6 months in the Kisqali/fulvestrant group, compared to 51.8 months in the fulvestrant alone group.
Additionally, patients receiving the two-drug combination went a longer period of time before the use of the next chemotherapy, with an average of 49.2 months compared to 29 months in the Kisqali/fulvestrant and fulvestrant groups, respectively. Thirty-nine (16.5%)patients in the Kisqali group were still undergoing treatment with the therapy at the later follow-up date, with no new side effects observed.
Estimated five-year survival was also improved with the Kisqali regimen, with 56.5% of patients alive at the five-year mark, compared to 42.1% in those who received fulvestrant alone.
Read more: Treatment Combination Breaks the ‘5-Year Ceiling’ in Metastatic Breast Cancer
“The unique profile of Kisqali continues to be reinforced, with results from MONALEESA-3 pushing the boundaries of how using a Kisqali-combination treatment regimen can extend lives of postmenopausal women living with HR+/HER2- advanced breast cancer without compromising quality of life,” said Jeff Legos, executive vice president and Global Head of Oncology & Hematology Development at Novartis, the manufacturer of Kisqali, said in the release.
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