Asco 2019 – Novartis looks to premenopausal survival to reinvigorate Kisqali

Novartis’s CDK4/6 inhibitor Kisqali has not had it easy. Its 2017 breast cancer launch disappointed, and the drug has fallen behind Pfizer’s Ibrance and Lilly’s Verzenio, which act similarly. The Swiss firm will hope that the overall survival benefit disclosed at Asco today in Kisqali’s Monaleesa-7 study might change things. The drug’s first approval came on the basis of Monaleesa-2, in first-line ER-positive, Her2-negative women who were postmenopausal, and last year the FDA extended the label to the premenopausal setting, based on a 13.7-month progression-free survival benefit seen in Monaleesa-7. At Asco today investigators said overall survival at 42 months’ follow-up in Monaleesa-7 was 70% for Kisqali versus 46% for control, translating into a 28.8% reduction in risk of death (p=0.00973, median not reached for the active cohort). No doubt Novartis will want to capitalise on this finding, especially as Kisqali remains the only one of the CDK4/6 inhibitor trio to carry the first-line premenopausal setting on its label. Still, in ER-positive, Her2-negative breast cancer Novartis’s biggest immediate hope is the PI3K inhibitor alpelisib, which as Piqray recently scored its first US approval, in second-line patients, on the strength of the Solar-1 trial.

Overall survival in Monaleesa-7. Source: Asco & NEJM.

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