Swiss pharma giant Novartis (NOVN: VX) has been advised to stop its Phase III trial of LEE011 (ribociclib) for advanced breast cancer as it met the primary endpoint.
The Monaleesa-2 independent data monitoring committee has recommended stopping the trial early as it met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, at pre-planned interim analysis.
Monaleesa-2 is a pivotal Phase III trial of LEE011, a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone.
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