Drug updated on 4/18/2024
| Dosage Form | Tablet (oral; 50 mg, 150 mg, 200 mg) |
| Drug Class | Kinase 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.
Summary
- Alpelisib (Piqray) is indicated in combination with fulvestrant for the treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative, PIK3CA-mutated advanced or metastatic breast cancer. It has shown superior clinical efficacy as a second-line treatment compared to other PI3K/AKT/mTOR inhibitors.
- The analysis was based on five systematic reviews/meta-analyses, providing an extensive evaluation based on their studies.
- Compared to CDK4/6 inhibitors such as abemaciclib, ribociclib, and palbociclib, combined with fulvestrant, alpelisib maintains a credible safety margin similar to its counterparts while presenting superior clinical efficacy for HR-positive, HER2-negative metastatic breast cancer patients.
- In considering specific populations and subgroups, particularly those with PIK3CA mutation epidemiology, combining alpelisib with endocrine therapy improves response rates and progression-free survival compared to endocrine therapy alone.
- Adverse events associated with alpelisib include hyperglycemia, diarrhea, nausea, and rash. Despite these clinically relevant adverse events leading to an 18% discontinuation rate among patients under this drug regimen, no treatment-related deaths were reported, indicating its relative safety profile.
- Alpelisib's beneficial impact is especially noted in patients exhibiting HR+/HER2-, PIK3CA-mutant metastatic breast cancer—a population subgroup that shows substantial clinical benefit from this targeted therapeutic approach.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Piqray (alpelisib) Prescribing Information. | 2024 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Biomarkers for systemic therapy in metastatic breast cancer: ASCO guideline update. | 2022 | Journal of Clinical Oncology |
| Endocrine treatment and targeted therapy for hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: ASCO guideline update. | 2021 | Journal of Clinical Oncology |
| Treating Breast Cancer. | 2020 | American Cancer Society |
| 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). | 2020 | Annals of Oncology |