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Found 1 Presentation For Request "309P"

Poster Display session

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)

Presentation Number
309P
Speakers
  • Stuart Turner (East Hanover, NJ, United States of America)
Date
17.09.2020

Abstract

Background

BYLieve (NCT03056755) confirmed efficacy and safety of ALP + FUL for HR+, HER2−, PIK3CA-mut ABC in the post-CDK4/6 inhibitor (CDKi) setting. Further analyses were performed to compare efficacy results from BYLieve with standard treatment in the real-world setting.

Methods

Pts who progressed on CDKi + aromatase inhibitor (AI) and were treated with ALP + FUL in BYLieve were compared to pts from the de-identified Flatiron Health-Foundation Medicine Clinico-Genomics Database (CGDB) who had similar baseline covariates. Two real-world cohorts were retrieved from CGDB based on post-CDKi treatment in the real-world setting: first cohort excluded pts with HER2+ drugs, clinical study drug, or alpelisib, and second cohort excluded pts with drugs from first cohort or chemotherapy. 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. Weighting by odds, propensity score matching, and exact matching were performed separately for each endpoint.

Results

855 pts with PIK3CA mut and prior CDKi + hormone therapy were identified from CGDB; further matching to 120 pts from BYLieve identified 95 pts without HER2+ drugs, clinical study drug, or alpelisib and 65 pts from CGDB without these drugs or chemotherapy. 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.

Progression-free survival (PFS) pre and post weighting/matching

Method Median PFS, mo (95% CI) [real-world PFS for CGDB] PFS at 6 mo, %
BYLieve: ALP + FUL CGDB: Standard treatment BYLieve: ALP + FUL CGDB: Standard treatment, excluding chemo BYLieve: ALP + FUL CGDB: Standard treatment BYLieve: ALP + FUL CGDB: Standard treatment, excluding chemo
Unadjusted 7.3 (5.6-8.3) 3.6 (3.1-6.1) 7.3 (5.6-8.3) 3.4 (2.9-3.9) 54.6 40.5 54.6 32.9
Weighting by odds 7.3 (5.6-8.3) 3.7 (3.1-6.1) 7.3 (5.6-8.3) 3.4 (2.8-5.1) 54.6 40.1 54.6 28.8
Propensity score 8.0 (5.6-8.6) 3.5 (3.0-5.4) 7.0 (5.3-8.6) 3.4 (2.8-3.7) 58.7 37.4 54.6 29.9
Exact 6.5 (5.3-8.3) 3.4 (2.9-3.9) 6.0 (5.1-8.3) 3.4 (2.8-3.8) 54.4 34.4 52.4 29.3

Conclusions

Comparing data from BYLieve with the real-world setting further supports the clinical benefit of ALP + FUL for treatment of HR+, HER2−, PIK3CA-mut ABC post-CDKi treatment.

Editorial acknowledgement

Medical editorial assistance was provided by Rob M. Camp of Healthcare Consultancy Group, LLC, and funded by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

S. Turner: Full/Part-time employment: Novartis. S.K.L. Chia: Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self): Eli Lilly; Honoraria (self), Research grant/Funding (institution): Hoffman LaRoche; Honoraria (self), Research grant/Funding (institution): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Genomic Health. H. Kanakamedala: Advisory/Consultancy, Research grant/Funding (institution): Novartis. W-C. Hsu: Advisory/Consultancy, Research grant/Funding (institution): Novartis. J. Park: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. D. Chandiwana: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. A. Ridolfi: Full/Part-time employment: Novartis. C-L. Yu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. J.P. Zarate: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis; Spouse/Financial dependant: Johnson & Johnson. H.S. Rugo: Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution): Merck; Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): OBI Pharma; Research grant/Funding (institution): Odonate Therapeutics; Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi-Sankyo; Research grant/Funding (institution): Eisai; Research grant/Funding (institution), Travel/Accommodation/Expenses: Macrogenics; Travel/Accommodation/Expenses: Mylan; Research grant/Funding (institution): Immunomedics; Advisory/Consultancy: Samsung; Advisory/Consultancy: Celtrion; Travel/Accommodation/Expenses: AstraZeneca.

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