At the pre-specified final OS analysis, there was no significant difference in OS between the PIQRAY plus fulvestrant arm and the placebo plus fulvestrant arm (hazard ratio [HR] = 0.86, 95% CI: 0.64, 1.15).1
After one line of CDK4/6 inhibitor + ET, offer alpelisib (PIQRAY®) + fulvestrant3,4*
Category 1 preferred option recommended by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for postmenopausal women and men with metastatic HR+/HER2- PIK3CA-mutated tumors4
*Unless a recurrence or unmanageable toxicity occurs, per HR+/HER2- MBC American Society of Clinical Oncology® Guideline Update 2021.
Highlights of Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.
Serious adverse reactions include severe hypersensitivity, severe cutaneous adverse reactions, hyperglycemia, pneumonitis, diarrhea or colitis, and embryo-fetal toxicity.
Most common adverse reactions including laboratory abnormalities (all grades, incidence ≥20%) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, gamma-glutamyl transferase increased, nausea, alanine aminotransferase increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, activated partial thromboplastin time prolonged, and alopecia.
Please see additional Important Safety Information below. Please see full Prescribing Information.
Consistent PFS was seen across subgroups, including those with prior CDK4/6 inhibitor + AI or primary/secondary endocrine resistance5
PFS in select patient subgroups with a PIK3CA mutation5
The data are from prespecified subgroup analyses of the primary endpoint (mPFS) in SOLAR-1 and are not powered to detect statistical significance.
aIn the SOLAR-1 study, first line was defined as patients whose disease progressed ≤1 year after (neo)adjuvant ET or whose disease progressed >1 year after (neo)adjuvant ET, and who did not receive prior treatment for aBC. Second line was defined as patients whose disease progressed >1 year after (neo)adjuvant ET and while on or after one line of ET for aBC or patients with newly diagnosed aBC whose disease progressed while on or after one line of ET.
bIn the SOLAR-1 study, primary endocrine resistance was defined as relapse within 24 months on adjuvant ET or progression within 6 months on ET for advanced disease. Secondary endocrine resistance was defined as relapse after 24 months on adjuvant ET, relapse within 12 months of the end of adjuvant ET, or progression after 6 months on ET for advanced disease. Endocrine sensitive was defined as relapse ≥12 months after completion of ET in the adjuvant setting.
AI, aromatase inhibitor; CDK, cyclin D–dependent kinase; ET, endocrine therapy; mPFS, median progression-free survival; PFS, progression-free survival.
