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Alpelisib, a pill blocking the mutated PI3K-alpha enzyme, nearly doubled the time to progression when added to fulvestrant in advanced breast cancer carrying a PIK3CA mutation, at the cost of high blood sugar and rash.
Phase 3 placebo-controlled trial of 572 patients with hormone receptor-positive, HER2-negative advanced breast cancer after an aromatase inhibitor, randomised to alpelisib or placebo with fulvestrant, stratified by PIK3CA mutation status.
In the 341 patients with PIK3CA-mutated tumours, median progression-free survival was 11.0 versus 5.7 months (hazard ratio 0.65); no benefit was seen without the mutation. Hyperglycaemia, rash and diarrhoea led to frequent dose changes.
PIK3CA testing became routine in advanced hormone receptor-positive breast cancer, with alpelisib-fulvestrant the first approved PI3K-targeted regimen; capivasertib and inavolisib now offer alternatives.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, New England Journal of Medicine.
Shares Alpelisib, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares Alpelisib, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares Alpelisib, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares Alpelisib, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares Alpelisib, HR-positive metastatic breast cancer after CDK4/6 inhibitors.
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, New England Journal of Medicine.