PIQRAY® (alpelisib) | PIK3CA-mutated advanced breast cancer

For Healthcare Professionals Outside the US

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- aBC1,2

A total of 572 patients were enrolled in the trial, including 341 patients with a PIK3CA mutation
Patients were stratified by:
  • 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 design for cohort with a PIK3CA mutation
A total of 231 patients did not have a PIK3CA mutation and were included as a separate cohort as a proof of concept to evaluate PIQRAY as a biomarker-driven therapy. The proof of concept criteria were not met for this cohort.2

Primary endpoint1,2

Progression-free survival (PFS) in patients with a PIK3CA mutation (investigator assessment)

Key secondary endpoint1,2

Overall survival in patients with a PIK3CA mutation

Additional secondary endpoints1-3

Overall response rate in patients with a PIK3CA mutation

Clinical benefit rate in patients with a PIK3CA mutation

Safety

Health-related quality-of-life (HRQOL)

AI, aromatase inhibitor; CDK, cyclin D–dependent kinase; ECOG, Eastern Cooperative Oncology Group; IM, intramuscularly; PO, orally.
*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 represented1,2

Baseline characteristics of patients with a PIK3CA mutation2,3
Characteristica PIQRAY + fulvestrant
(n=169)b 		Plabeco + fulvestrant
(n=172)c
Line of advanced anticancer treatmentd
First line 88 (52.1) 89 (51.7)
Second line 79 (46.7) 82 (47.7)
Median age, years (range) 63 (25-87) 64 (38-92)
Race
Caucasian 117 (69.2) 109 (63.4)
Asian 34 (20.1) 40 (23.3)
Other/unknown 18 (10.7) 23 (13.4)
ECOG performance status
0 112 (66.3) 113 (65.7)
1 56 (33.1) 58 (33.7)
Metastatic sites
Visceral disease 93 (55.0) 100 (58.1)
Lung metastasis 57 (33.7) 68 (39.5)
Liver metastasis 49 (29.0) 54 (31.4)
Bone-only disease 42 (24.9) 35 (20.3)
Prior chemotherapy
Neoadjuvant 25 (14.8) 29 (16.9)
Adjuvant 78 (46.2) 86 (50.0)
Prior CDK4/6 inhibitor treatment 9 (5.3) 11 (6.4)
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.
References: 1. Piqray® (alpelisib) EU Summary of Product Characteristics. Novartis; 2022. 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; 2018.