Summary

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• Piqray (alpelisib) is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
• The summary is based on the review of five systematic reviews/meta-analyses. ^[1-5]
• Alpelisib plus fulvestrant significantly improves Progression-Free Survival (PFS) in HR+/HER2- and PIK3CA-mutated metastatic breast cancer populations compared to fulvestrant alone or anastrozole alone.
• PI3K inhibitors, including alpelisib, show a notable improvement in Overall Response Rate (ORR) for PIK3CA-mutated breast cancer patients, with significant differences observed when compared to placebo.
• No significant difference in Overall Survival (OS) was observed with alpelisib plus fulvestrant compared to other treatments such as abemaciclib, ribociclib, or buparlisib.
• Alpelisib was associated with significant adverse drug events (ADEs), including hyperglycemia (59% all-grade, 28% grade 3/4), diarrhea (56%), nausea (44%), and rash (38%, with 10% grade 3/4). Additionally, 18% of patients discontinued treatment due to ADEs.
• No treatment-related deaths were observed with alpelisib, though there was a high incidence of hyperglycemia and rash among patients.
• The reviewed studies focus primarily on postmenopausal women with HR+, HER2- metastatic breast cancer, with particular attention to PIK3CA-mutated subgroups, underscoring the relevance of PIK3CA mutation testing for personalized treatment approaches in this population.