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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Piqray (alpelisib) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
LBA18 - Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC)
Published date:
09/19/2020
Excerpt:
With mOS follow-up of 30.8 mo, mOS was 39.3 mo (95% CI 34.1-44.9) with ALP + FUL and 31.4 mo (95% CI 26.8-41.3) with PBO + FUL (HR 0.86; 95% CI 0.64-1.15; P=0.15); OS did not cross the prespecified boundary….Though not statistically significant, OS was prolonged by a clinically relevant ≈8 mo with ALP when added to FUL in...PIK3CA-mut ABC.
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve)
Excerpt:
...Patient has a PIK3CA mutation confirmed by Novartis designated central lab or patient has a pathology report confirming PIK3CA mutant status by certified laboratory (using validated PI3KCA mutation assay) either from tissue or blood and must (mandatory) send tumor tissue to Novartis designated central lab for confirmation of mutational status...
Trial ID:
Source:
Title:
Clinical and biomarker results from phase I/II study of PI3K inhibitor alpelisib plus nab-paclitaxel in HER2-negative metastatic breast cancer
Published date:
02/18/2021
Excerpt:
Alpelisib plus nab-paclitaxel combination was well-tolerated and shows encouraging efficacy, especially in patients with PIK3CA-mutated tumor/ctDNA.
DOI:
10.1158/1078-0432.CCR-20-4879
Source:
Title:
163P - Population-adjusted comparison of SOLAR-1 and BOLERO-2: PFS with second-line alpelisib + fulvestrant vs everolimus + exemestane in postmenopausal pts with PIK3CA-mut hormone-receptor positive (HR+) human epidermal growth factor receptor-2 negative (HER2-) advanced breast cancer (ABC)
Published date:
05/24/2020
Excerpt:
Analysis of comparable populations from the SOLAR-1 and BOLERO-2 trials suggest A+F may yield clinically and statistically significant improvement in PFS compared with E+E as 2L trt for postmenopausal women with PIK3CA-mut, HR+, HER2– ABC…
Secondary therapy:
fulvestrant
Source:
Title:
Alpelisib (ALP) + fulvestrant (FUL) in patients (pts) with PIK3CA-mutated (mut) hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) previously treated with cyclin-dependent kinase 4/6 inhibitor (CDKi) + aromatase inhibitor (AI): BYLieve study results.
Published date:
05/13/2020
Excerpt:
127 pts whose immediate prior tx was CDKi + AI were enrolled, of whom 121 had centrally confirmed PIK3CA mut; median follow-up was 11.7 mo. Primary endpoint was met: proportion of pts without disease progression at 6 mo was 50.4% (95% CI, 41.2-59.6).
Secondary therapy:
fulvestrant
DOI:
10.1200/JCO.2020.38.15_suppl.1006
Trial ID:
Source:
Title:
Clinical and biomarker results from phase I/II study of PI3K inhibitor BYL 719 (alpelisib) plus nab-paclitaxel in HER2-negative metastatic breast cancer
Published date:
05/16/2018
Excerpt:
Alpelisib and nP combination shows encouraging efficacy with manageable toxicity in HER2 negative MBC….Efficacy was especially robust in patients with PIK3CA mutation (ORR = 65%, PFS = 13months).
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.1200/JCO.2018.36.15_suppl.1018
Trial ID:
Source:
Title:
Alpelisib Impresses in PIK3CA+ Breast Cancer After Progression on CDK Inhibition
Excerpt:
121 patients, 50.4% (n = 61) were alive and progression-free at 6 months. The 95% confidence interval was 41.2% to 59.6%, meeting the study’s primary end point with a lower bound of greater than 30%. The median progression-free survival (PFS) was 7.3 months (95% CI, 5.6-8.3)...The combination of alpelisib and fulvestrant has demonstrated clinically meaningful efficacy in patients with PIK3CA-mutated, HR-positive/HER2-negative advanced disease who progressed on treatment with CDK4/6 inhibitors plus an aromatase inhibitor...
Secondary therapy:
fulvestrant
Trial ID:
