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Novartis CDK4/6 Profile Boosted But Challenge To Pfizer Rival Uncertain

 
• By Sten Stovall

Novartis' Phase III MONALEESA-2 trial shows that ribociclib plus letrozole has strong efficacy and an acceptable tolerability profile for first-line advanced HR+/HER2- breast cancer patients, but analysts say the results do not surpass those of Pfizer's first-to-market Ibrance plus letrozole in a similar setting.

Novartis AG has released strong interim data from its Phase III MONALEESA-2 trial evaluating LEE011 (ribociclib) for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced/metastatic breast cancer, increasing the likelihood its cyclin-dependent kinase 4/6 inhibitor will be second to market behind Pfizer Inc.'s CDK 4/6 inhibitor Ibrance (palbociclib) and ahead of Eli Lilly & Co.'s abemaciclib.

Still, some analysts said safety concerns raised by data in MONALEESA-2 may curb commercial prospects for the Novartis therapy once...

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