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Novartis' SOLAR-1 Study Shines on Alpelisib In Breast Cancer

 
• By John Davis

The selective PI3K inhibitor, alpelisib, met its primary PFS endpoint in top-line data from the SOLAR-1 study, but further details are needed from the trial in order to judge the drug's likely penetration of the HR-positive, HER2-negative breast cancer population.  

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• Source: Shutterstock

Novartis AG's PI3K inhibitor, alpelisib (BYL719), has met the primary endpoint in the global Phase III SOLAR-1 trial, showing an improvement in progression-free survival (PFS) in patients with PIK3CA-mutated HR+/HER2- breast cancer.

The Basel, Switzerland-based multinational says the results will lead to the start of discussions on marketing submissions with regulatory authorities worldwide.

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