PI3K阻害薬BYL719(alpelisib)、PIK3CA遺伝子変異陽性のHR陽性HER2陰性進行乳がんに対して、フルベストラントとの併用投与を検証した第Ⅲ相試験SOLAR-1で主要評価項目を達成【スイス・NOVARTIS】

主要評価項目は無増悪生存期間(PFS)。詳細は今後の学会で発表される予定。

SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation

・SOLAR-1 evaluated BYL719 plus fulvestrant vs. fulvestrant alone in HR+/HER2- advanced breast cancer patients with PIK3CA mutations who progressed on or following treatment with an aromatase inhibitor with or without a CDK4/6 inhibitor
・Approximately 40% of HR+ advanced breast cancer patients have PIK3CA mutations, and the PI3K pathway is the most commonly mutated pathway associated with tumor progression in HR+ advanced breast cancer
・Full results will be submitted to an upcoming medical congress and Novartis will initiate discussions with regulatory authorities worldwide

 

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