publication date: Oct. 20, 2016

Breast Cancer Novartis’s LEE011 + Letrozole Shows Superior PFS as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

Results from the pivotal phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS), compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months – not reached) vs 14.7 months (13.0 – 16.5 months); HR=0.556; p=0.00000329.

Novartis presented the results at the European Society for Medical Oncology (ESMO) 2016 Congress and presented as a late-breaker during the Presidential Symposium.

The results were also published simultaneously online in The New England Journal of Medicine.

The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone. The combination significantly improved PFS across all patient subgroups, regardless of disease characteristics or demographics. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028).

“The MONALEESA-2 results show the combination of LEE011 plus letrozole represents a significant step forward in the management of HR+ metastatic breast cancer and, if approved, would be a major addition to the … Continue reading CCL Oct 2016 – Novartis’s LEE011 + Letrozole Shows Superior PFS as First-Line Treatment for HR+/HER2- Advanced Breast Cancer

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