Ribociclib regimen continues to show survival benefit in postmenopausal breast cancer
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The addition of ribociclib to fulvestrant conferred a survival benefit of nearly 16 months as first-line treatment for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer, topline data showed.
Updated OS results of the phase 3 MONALEESA-3 study, scheduled for presentation during ESMO Breast Cancer Congress, included median follow-up of 5 years among women who received ribociclib (Kisqali, Novartis) plus fulvestrant vs. fulvestrant alone in the first-line setting, according to a Novartis press release.
Previous results presented during the 2019 ESMO Congress showed a statistically significant improvement in OS among ribociclib-treated women (median, not reached vs. 40 months; HR = 0.72; 95% CI, 0.56-0.92). The new analysis showed median OS of 67.6 months in the ribociclib group (n = 237) vs. 51.8 months in the fulvestrant-alone group (n = 128), representing a 33% relative reduction in the risk for death (HR = 0.67; 95% CI, 0.5-0.89), according to the press release.
In addition, women who received ribociclib had a longer delay to subsequent use of chemotherapy (49.2 months vs. 29 months; HR = 0.62; 95% CI, 0.48-0.8), as well as a higher estimated survival rate at 5 years (56.5% vs. 42.1%), the press release stated.
A larger proportion of women in the ribociclib group vs. the fulvestrant-alone group remained on therapy at the extended follow-up (16.5%, n = 39 vs. 8.6%, n = 11), and researchers observed no new adverse events with the combination.
“MONALEESA-3 results continue to demonstrate the survival benefit of treatment with ribociclib for postmenopausal women with advanced breast cancer,” Dennis J. Slamon, MD, PhD, director of clinical/translational research at UCLA Jonsson Comprehensive Cancer Center, said in the press release. “Whether partnered with fulvestrant or an aromatase inhibitor in the first-line setting, ribociclib offers oncologists a CDK 4/6 inhibitor with consistent benefit in providing women with [hormone receptor-positive]/HER2-negative advanced breast cancer more quality time, regardless of their disease characteristics.”
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