publication date: Jun. 2, 2016

Breast Cancer

LEE011 Meets Primary Endpoint, Improves PFS in Phase III Trial


An independent data monitoring committee found that a phase III trial of LEE011 (ribociclib) had met its primary endpoint of improving progression-free survival in patients with advanced breast cancer, and recommended that it be stopped early.

The trial, MONALEESA-2, is evaluating LEE011, a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone, in postmenopausal women who had received no prior therapy for HR+/HER2- advanced breast cancer.

“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,” said Alessandro Riva, global head of oncology development and medical affairs for Novartis Oncology, the study’s sponsor.

The adverse events observed with LEE011 in combination with letrozole in MONALEESA-2 were generally consistent with their respective known adverse event profiles. Full results will be presented at an upcoming medical congress, and Novartis plans to initiate discussions with regulatory authorities worldwide. The trial will continue to assess overall survival data.

MONALEESA-2 … Continue reading CCL May – Breast Cancer LEE011 Meets Primary Endpoint, Improves PFS in Phase III Trial

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