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Association details:

Evidence:

Evidence Level:
Sensitive: A1 - Approval
New
Title:
Alpelisib (Piqray®) is not recommended for use within NHSScotland
Published date:
01/15/2021
Excerpt:
CONTRADICTING EVIDENCE: Alpelisib (Piqray®) is not recommended for use within NHSScotland....in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Title:
PIQRAY® is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR-positive, HER2-negative advanced breast cancer
Published date:
08/13/2020
Excerpt:
Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that PIQRAY® (alpelisib) is approved and now available in Canada. PIQRAY® in combination with fulvestrant is indicated for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Published date:
07/27/2020
Excerpt:
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy...
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
PIQRAY is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, 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.
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
For HR-positive/HER2-negative breast cancer, assess for PIK3CA mutations with tumor or liquid biopsy identify candidates for alpelisib plus fulvestrant.
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
NCCN recommendations for second-line: For postmenopausal women with HR-positive, HER2-positive recurrent/stage IV breast cancer, the preferred options available include…those with tumor PIK3CA mutations, fulvestrant with alpelisib…
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Alpelisib Plus Fulvestrant for PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2-Negative Advanced Breast Cancer: Final Overall Survival Results From SOLAR-1
Published date:
11/24/2020
Excerpt:
Men and postmenopausal women with HR+, HER2- ABC whose disease progressed on or after aromatase inhibitor (AI) were randomized 1:1 to receive alpelisib (300 mg/day) plus fulvestrant (500 mg every 28 days and once on Day 15) or placebo plus fulvestrant….In the PIK3CA-mutated cohort (n=341), median OS (95% confidence interval [CI]) was 39.3 months (34.1-44.9) for alpelisib-fulvestrant and 31.4 months (26.8-41.3) for placebo-fulvestrant (hazard ratio [HR] = 0.86 [95% CI, 0.64-1.15; P=0.15])....there was a 7.9-month numeric improvement in median OS when alpelisib was added to fulvestrant treatment for patients with PIK3CA-mutated, HR+, HER2- ABC.
Secondary therapy:
fulvestrant
DOI:
10.1016/j.annonc.2020.11.011
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Clinical outcomes of alpelisib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer with PIK3CA alterations detected in plasma ctDNA by next-generation sequencing: Biomarker analysis from the SOLAR-1 study
Published date:
11/17/2020
Excerpt:
ALP plus FUL prolonged mPFS in pts with PIK3CA alterations detected in plasma ctDNA by NGS…
Secondary therapy:
fulvestrant
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
309P - Real-world effectiveness of alpelisib (ALP) + fulvestrant (FUL) compared with standard treatment among patients (Pts) with hormone-receptor positive (HR+) human epidermal growth factor receptor-2 negative (HER2–) PIK3CA-mutated (Mut) advanced breast cancer (ABC)
Published date:
09/14/2020
Excerpt:
Primary and secondary endpoints were to evaluate and compare progression-free survival and proportion of pts remaining progression free at 6 mo after the index date (date of the start of the next line of therapy), respectively, with ALP + FUL in BYLieve vs. CGDB real-world cohorts....In unadjusted results and in 3 methods to weight/match pts, primary and secondary endpoints consistently favored treatment with ALP + FUL in BYLieve over standard treatments in either real-world cohort.
Secondary therapy:
fulvestrant
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:
Alpelisib (ALP) + fulvestrant (FUL) for advanced breast cancer (ABC): Results of the phase III SOLAR-1 trial
Published date:
10/01/2018
Excerpt:
ALP+FUL met the primary endpoint by significantly extending PFS vs PBO+FUL and demonstrated a manageable tolerability profile. This is the first study to show statistically significant, clinically meaningful PFS treatment improvement with an α-specific PI3K inhibitor in PIK3CA-mut HR+, HER2– ABC.
Secondary therapy:
fulvestrant
DOI:
https://doi.org/10.1093/annonc/mdy424.010
Evidence Level:
Sensitive: B - Late Trials
Title:
Alpelisib for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer
Excerpt:
Treatment with alpelisib–fulvestrant prolonged progression-free survival among patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously.
Secondary therapy:
fulvestrant
DOI:
10.1056/NEJMoa1813904
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Effectiveness of Alpelisib + Fulvestrant Compared With Real-World Standard Treatment Among Patients With HR+, HER2–, PIK3CA-Mutated Breast Cancer
Published date:
04/28/2021
Excerpt:
...median PFS for patients treated with alpelisib in BYLieve was 7.3 versus 3.7 months in the real‐world cohort, and 6‐month PFS was 54.6% versus 40.1%, respectively....clinical benefit of alpelisib with fulvestrant for treatment of HR+, HER2−, PIK3CA‐mutant ABC post‐CDK4/6i treatment.
Secondary therapy:
fulvestrant
DOI:
https://doi.org/10.1002/onco.13804
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study
Published date:
04/01/2021
Excerpt:
...median progression-free survival was 6∙0 months (95% CI: 3∙7-8∙4), and 1-year overall survival was 59∙1% (95% CI: 45∙8-76∙2)....BYLieve showed activity of alpelisib plus fulvestrant with manageable toxicity in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer, after progression on a CDK4/6 inhibitor plus an aromatase inhibitor.
Secondary therapy:
fulvestrant
DOI:
10.1016/S1470-2045(21)00034-6
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
Alpelisib + letrozole in patients with PIK3CA-mutated, hormone-receptor positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) previously treated with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + fulvestrant: BYLieve study results
Published date:
11/17/2020
Excerpt:
Treatment with the p110α-selective PI3K inhibitor, alpelisib (BYL719), completely blocked the progression of acquired CDK4/6 inhibitor-resistant xenografts in the absence of continued CDK4/6 inhibitor treatment in models of both PIK3CA mutant and wild-type ER+/HER2- breast cancer.
Secondary therapy:
letrozole
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