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

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PIQRAY + fulvestrant nearly doubled mPFS in patients with a PIK3CA mutation1,2

PFS in patients with a PIK3CA mutation1,2
mPFS was 11.0 months with PIQRAY + fulvestrant versus 5.7 months with placebo + fulvestrant (HR=0.65) (95% CI, 0.50-0.85; P=.0013) mPFS was 11.0 months with PIQRAY + fulvestrant versus 5.7 months with placebo + fulvestrant (HR=0.65) (95% CI, 0.50-0.85; P=.0013)
Results reported at 2 months were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error

Rapid separation of PFS curve evident at 2 months1,2

Approximately 8 months of OS benefit3
  • Median OS was 39.3 months (95% CI, 34.1-44.9) for PIQRAY + fulvestrant vs 31.4 months (95% CI, 26.8-41.3) for placebo + fulvestrant (HR=0.86; [95% CI, 0.64-1.15] P=.15)
PIQRAY and fulvestrant mechanism of action graphic PIQRAY and fulvestrant mechanism of action graphic
mPFS, median progression-free survival; PFS, progression-free survival.

Consistent PFS results across subgroups1,2

PFS in select patient subgroups with a PIK3CA mutation2
PFS in select patient subgroups with a PIK3CA mutation PFS in select patient subgroups with a PIK3CA mutation
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.3

More than doubled the response rate1,2

ORR in patients with a PIK3CA mutation who had measurable disease1,2
ORR_chart 2 ORR_chart 2
ORR in all patients with a PIK3CA mutation2
ORR_chart 1 ORR_chart 1
ORR was defined as the percentage of subjects with confirmed complete response or partial response. Measurable disease was defined as the presence of at least one measurable nodal or non-nodal lesion as per RECIST v1.1 criteria.
ORR, overall response rate.

Tumor shrinkage was observed in 3 out of 4 patients with a PIK3CA mutation5

Best percentage change in tumor size in patients with a PIK3CA mutation5
Best percentage change in tumor size in patients with a PIK3CA mutation Best percentage change in tumor size in patients with a PIK3CA mutation
A total of 43.5% (n/N=57/131) of patients in the placebo + fulvestrant arm experienced a reduction in tumor size. Reduction in tumor size was defined as any amount of tumor shrinkage from baseline. Results are based on best percentage change from baseline in sum of diameters per investigator assessment in the cohort with a PIK3CA mutation where only subjects with measurable disease at baseline are presented. Results reported were not prespecified and are observational in nature; as such, there was no prespecified statistical procedure controlling for type 1 error. Subjects for whom the best percent change in target lesions was not available or was contradicted by overall lesion response were excluded from the analysis.

Additional results

cardSimilar EORTC QLQ-C30 global health status/QoL scores in both arms in the PIK3CA mutant cohort6

There was no statistical difference between the two treatment arms in time to 10% deterioration (TTD) in EORTC QLQ-C30 global health/QoL status (HR=1.03; 95% CI, 0.72-1.48)*

timeDelayed time to chemotherapy (TTC) by 8.5 months3

PIQRAY + fulvestrant delayed median TTC by 8.5 months vs placebo + fulvestrant (23.3 months vs 14.8 months; HR=0.72 [95% CI, 0.54-0.95]) which is meaningful to patients

EORTC-QLQ-C30, European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire.
*TTD in global health status EORTC QLQ-C30 was defined as time between baseline and first occurrence of ≥10 point worsening of global health status (EORTC QLQ-C30 global health scale score) compared to baseline with no later improvement above this threshold observed during the treatment period or death due to any cause.
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. André F, Ciruelos E, Juric D, et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-1–negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2020;32(2):208-217. 4. Data on file. Novartis Pharmaceuticals Corp; 2021. 5. Data on file. Novartis Pharmaceuticals Corp; 2018. 6. Ciruelos EM, Rugo HS, Mayer IA, et al. Patient-reported outcomes in patients with PIK3CA mutated hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer from SOLAR-1. J Clin Oncol. Published online March 29, 2021. doi:10.1200/JCO.20.01139.