Novartis Ups Pace On Ibrance Challenger As Ribociclib Trial Stopped Early

18 May 2016

• By Sukaina Virji

Novartis's Phase III MONALEESA-2 trial of its CDK4/6 inhibitor ribociclib has been stopped early on positive interim data. The study was conducted in first-line metastatic, hormone-positive breast cancer patients, a market estimated to be worth $6bn in the US alone.

An independent data monitoring committee recommended stopping the MONALEESA-2 trial early as results of a pre-planned interim analysis showed the trial met the primary endpoint of progression-free survival (PFS), Novartis AG announced May 18.

MONALEESA-2 is a pivotal Phase III trial of ribociclib (LEE011), a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole,...