Breast cancer trial stopped after meeting primary endpoint early

pharmafile | May 18, 2016 | News story | Research and Development |  LEE011, Novartis, breast cancer, progression free survival, ribociclib 

A Phase III trial evaluating LEE011 (ribociclib), developed by Novartis, has been stopped early after a recommendation from an independent monitoring committee. The drug had already met its primary endpoint of significantly extending progression-free survival in patients with advanced breast cancer.

In the MONALEESA-2 trial, the cyclin dependent kinase inhibitor (CDK4/6), LEE011, was used in combination with letrozole and compared to treatment with letrozole alone in postmenopausal women who had received no prior treatment for their hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.

Novartis indicates that it will explore the use of expanded access programs in some regions to allow early access for women who benefit the drug.

Alessandro Riva, global head of oncology development and medical affairs at Novartis, says: “We are excited that these results validate our belief that LEE011 in combination with letrozole can be a beneficial treatment option for women diagnosed with HR+/HER2- advanced breast cancer.”

Sean Murray