Advanced Breast Cancer Outcome Improved with Femara, Ribociclib Combination

Advanced Breast Cancer Outcome Improved with Femara, Ribociclib Combination
Combining Norvartis' CDK4/6 inhibitor ribociclib with Femara (letrozole) may be a promising first-line therapy for hormone receptor (HR)-positive breast cancer patients, according to recent data from a Phase 3 clinical trial. The results, recently presented at the European Society for Medical Oncology (ESMO) 2016 Congress, Oct. 7-11, in Copenhagen, show that the combination induced a 44 percent improvement in progression-free survival, compared to Femara alone. "This was the definitive study to demonstrate the superiority of the combination of ribociclib and letrozole over letrozole alone," principle investigator, professor Gabriel Hortobagyi, of the University of Texas MD Anderson Cancer Center in Houston, said in a press release. The results are part of the first interim analysis of the randomized, double-blind MONALEESA2 study (NCT01958021), that enrolled 668 postmenopausal women with HR-positive, HER-negative advanced breast cancer who had not received any prior systemic treatment or undergone surgery. Participants were randomized to receive ribociclib (600 mg/day; 3 weeks on/1 week off) in combination with Femara once a day, or a placebo plus Femara. Results revealed that the study met its primary endpoint, with ribociclib inducing a 44 percent improvement in progression-free survival compared to placebo. Median progression-free survival was 14.7 months in the placebo arm, and had not been reached in the ribociclib arm by the end of the study. "The results of this trial represent a compelling
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