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Alpelisib

(Piqray®)

Piqray®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 50 mg, 150 mg, 200 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • 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.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Effectiveness Outcomes: In a meta-analysis of randomized controlled trials, PI3K inhibitors, specifically alpelisib, demonstrated significant benefits in the PIK3CA-mutated group, with improved objective response rate (OR), progression-free survival (PFS), and notably superior 6-month PFS compared to fulvestrant.
  • Population and Treatment Recommendations: Alpelisib, in combination with endocrine therapy (ET), is recommended for postmenopausal and male patients with HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer (ABC) or metastatic breast cancer (MBC) who have previously received ET, with or without a CDK 4/6 inhibitor.
  • Comparative Effectiveness: Alpelisib was ranked first in 6-month PFS among PI3K inhibitors, surpassing other agents such as buparlisib, pictilisib, and taselisib, highlighting its potential for better outcomes in the specified patient population.
  • Adverse Events: The use of alpelisib is associated with significant adverse events (AEs), including hyperglycemia (59%), diarrhea (56%), nausea (44%), and rash (38%), with grade 3/4 hyperglycemia and rash reported in 28% and 10% of patients, respectively; 18% of patients discontinued treatment due to toxicities.
  • Safety Profile: Overall, PI3K inhibitors, including alpelisib, exhibited good safety profiles with few serious AEs, although specific safety outcomes were not detailed in the reviewed studies.