Home > Oncology > ASCO 2020 > BYLieve demonstrates efficacy of PIK3CA-directed treatment post CDK4/6-ihibition

BYLieve demonstrates efficacy of PIK3CA-directed treatment post CDK4/6-ihibition

The phase 2 BYLieve trial demonstrated that the combination of alpelisib and fulvestrant has a clinically meaningful efficacy in patients with *PIK3CA*-mutated hormone receptor (HR)-positive advanced breast cancer who progressed on treatment with CDK4/6 inhibitors plus an aromatase inhibitor, with manageable side effects.

*PIK3CA* is one of the most frequently mutated genes in breast cancer and a negative prognostic factor in HR-positive, HER2-negative advanced breast cancer. Approximately 40% of patients with this disease have a mutation of the *PIK3CA* gene in their tumour [1]. Alpelisib – an alpha-selective PI3 kinase inhibitor – plus fulvestrant recently demonstrated efficacy in the phase 3 SOLAR-1 trial in patients with HR-positive *PIK3CA*-mutant advanced breast cancer progressing on an aromatase inhibitor, nearly doubling the median progression-free survival (PFS) from 5.7 months in the placebo arm to 11 months in the alpelisib arm (HR 0.65; 95% CI ...



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