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SOLAR-1 was the first phase 3 trial leading to an approval specifically for aBC patients with a PIK3CA mutation1

  

Randomized, double-blind, prospective, placebo-controlled trial in HR+/HER2- aBC1

A total of 572 patients were enrolled in the trial, including 341 patients with a PIK3CA mutation1*
Patients were stratified by1:

  • Presence of liver and/or lung metastases

  • Prior CDK4/6 inhibitor treatment

SOLAR-1 study design for cohort with a PIK3CA mutation
SOLAR-1 study endpoints

231 of these patients did not have a PIK3CA mutation and were included as a separate cohort as a proof of concept, but the proof of concept criteria were not met for this cohort. No progression-free survival (PFS) benefit was observed in patients whose tumors did not have a PIK3CA tissue mutation (HR=0.85; 95% CI, 0.58-1.25).1

In the SOLAR-1 trial, patients with controlled type 2 diabetes and prediabetes were included if they had a fasting plasma glucose (FPG) of ≤140 mg/dL (7.7 mmol/L) and glycosylated hemoglobin (HbA1c) ≤6.4% (both criteria had to be met).1

AI, aromatase inhibitor; CDK, cyclin D–dependent kinase; ECOG, Eastern Cooperative Oncology Group; IM, intramuscularly; PO, orally.
*A total of 572 patients were enrolled in the SOLAR-1 trial but 571 patients were included in safety assessments.
Fulvestrant given on day 1 and day 15 of the first 28-day cycle, then day 1 of subsequent 28-day cycles. 

Patients with a broad range of characteristics were represented

Baseline characteristics of patients in SOLAR-1 with a PIK3CA mutation2,3 
Table for baseline characteristics of patients in SOLAR-1 with a PIK3CA mutation

aCharacteristics are given as n (%) unless otherwise stated.
bOne man was enrolled in the PIQRAY + fulvestrant arm. All other study participants were postmenopausal women.
cOne patient randomized to placebo was not treated.
dIn the SOLAR-1 study, first line was defined as patients whose disease progressed ≤1 year after (neo)adjuvant endocrine therapy (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.

Important Safety Information

PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.

Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, can occur in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms, including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia...

Indication

PIQRAY® (alpelisib) tablets 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...

Click or scroll to see IMPORTANT SAFETY INFORMATION AND INDICATION
References: 1. PIQRAY [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380(20):1929-1940. 3. Data on file. Novartis Pharmaceuticals Corp; 2021.