Lilly's Abemaciclib Hit Leaves It Down But Not Out
Continuation of Phase III MONARCH 2 study, with no early termination for efficacy, may mean a delay in filing and a tougher competitive outlook against Pfizer's Ibrance and Novartis' ribociclib.
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Lilly reported positive top-line results for abemaciclib in the Phase III MONARCH 2 trial and revealed a regulatory strategy that has it rapidly racing after competing CDK4/6 inhibitors already approved for certain breast cancer patients.
New England Journal of Medicine editorial sings the praises of CDK4/6 inhibitors in breast cancer, which include Pfizer's Ibrance, Novartis's ribociclib and Elli Lilly's abemaciclib.
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.