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Ribociclib Plus Letrozole Shows Overall Survival Benefit in HR+/HER2- Advanced Breast Cancer

Final analysis from the MONALEESA-2 trial showed an overall survival benefit that was more than 12 months longer for patients with HR+/HER2- advanced breast cancer on ribociclib versus placebo, according to a study in The New England Journal of Medicine. 

Ribociclib, a CDK4/6 inhibitor improved progression-free survival in previous studies.  

The phase 3 MONALEESA-2 trial set out to evaluate the safety and efficacy of ribociclib in combination with letrozole as a first line therapy for post-menopausal women with HR+/HER2- advanced breast cancer. 

In the primary and updated analyses of MONALEESA-2, patients given ribociclib plus letrozole had a significantly longer progression-free survival of 25.3 months, compared to 16 months for those treated with letrozole alone. 

The analysis for overall survival, a key secondary outcome of the trial, took place after a median follow-up of 6.6 years. 

At the time of follow-up, a total of 181 deaths out of the 334 patients (54.2%) in the ribociclib group occurred as well as 219 deaths out of the 334 patients (65.6%) in the placebo group.  

The median overall survival was 63.9 months for patients treated with ribociclib plus letrozole versus 51.4 months for patients treated with letrozole plus placebo. No new safety signals were reported in this final overall survival analysis. 

Overall, first-line therapy with ribociclib plus letrozole showed a significant overall survival benefit when compared to placebo plus letrozole in postmenopausal patients with HR+/HER2- advanced breast cancer. The median overall survival benefit was over 12 months longer for patients who received ribociclib. 

References:
https://www.nejm.org/doi/full/10.1056/NEJMoa2114663?query=TOC&cid=NEJM%20eToc 

https://www.novartis.com/news/media-releases/nejm-publication-novartis-kisqali-data-shows-longest-median-overall-survival-ever-reported-hrher2-advanced-breast-cancer 

Disclosures: All of the authors declared financial ties to drugmakers. See full study for details. 


By: MD /alert Staff 

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