Novartis’ Kisqali hits endpoints in Phase III breast cancer trial

More positive news to come out of the 2019 American Society of Clinical Oncology (ASCO) Meeting this week, as Novartis announces that its CDK4/6 inhibitor, Kisqali (ribociclib) significantly extends life in women with HR+/HER2- advanced breast cancer.

Data from the MONALEESA-7 trial found that after a median of 42 months follow-up, the survival rate was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone.

The results mean that Kisqali is the only CDK4/6 inhibitor to show superior overall survival in advanced breast cancer.

Overall survival benefit is considered the ‘gold standard’ in cancer trials but is "Challenging to achieve in HR+/HER2- metastatic breast cancer", said Sara Hurvitz, MD, medical director of the Jonsson Comprehensive Cancer Center Clinical Research Unit.

She continued, "MONALEESA-7 reached this important endpoint earlier than anticipated. Impactful results like these ribociclib findings are what we wish for in every clinical trial, and to achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement for patients."

The overall survival results were presented as a late-breaker at the 2019 ASCO Annual Meeting and will be published in The New England Journal of Medicine.

Kisqali is approved for use in more than 75 countries around the world, including the United States and European Union member states, and was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017.

Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old.

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