Found 1 Presentation For Request "349TiP"
349TiP - EPIK-B3: A phase III, randomised, double-blind (DB), placebo (PBO)-controlled study of alpelisib (ALP) + nab-paclitaxel (nab-PTX) in advanced triple-negative breast cancer (TNBC) with either PIK3CA mutation or phosphatase and tensin homolog (PTEN) loss without PIK3CA mutation
- Priyanka Sharma (Westwood, KS, United States of America)
Abstract
Background
TNBC has a high unmet need for novel therapies. Taxanes (T) are effective in advanced TNBC, but resistance often develops. PI3K pathway hyperactivation, driven by
Trial design
EPIK-B3 is a phase III trial in 3 parts evaluating ALP + nab-PTX as 1st or 2nd line of therapy (LoT) in advanced TNBC according to
Clinical trial identification
NCT04251533.
Editorial acknowledgement
Medical editorial assistance was provided by Karlo Dumaup, from Healthcare Consultancy Group, LLC, funded by Novartis Pharmaceuticals.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
P. Sharma: Honoraria (self), Research grant/Funding (institution): Merck; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): Celgene; Honoraria (self), Research grant/Funding (institution): Novartis; Honoraria (self): Pfizer; Honoraria (self): Daiichi-Sankyo; Honoraria (self): Puma Biotechnology; Honoraria (self): Myriad Genetic Laboratories; Honoraria (self): Seattle Genetics. A. Farooki: Advisory/Consultancy: Novartis; Advisory/Consultancy: Amgen; Advisory/Consultancy: Genentech; Advisory/Consultancy: Novo Nordisk. P.A. Fasching: Honoraria (self), Research grant/Funding (self): Novartis; Research grant/Funding (self): Biontech; Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self): Celgene ; Honoraria (self): Daiichi-Sankyo; Honoraria (self): AstraZeneca; Honoraria (self): Merck Sharp & Dohme; Honoraria (self): Myelo Therapeutics; Honoraria (self): Eisai; Honoraria (self): Puma; Research grant/Funding (self): Cepheid; Honoraria (self): Lilly. S. Loi: Research grant/Funding (institution): Aduro Biotech; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Novartis; Advisory/Consultancy: G1 Therapeutics; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Merck; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Roche-Genentech; Research grant/Funding (institution): Puma Biotechnology; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Acted as consultant (not compensated) : Seattle Genetics; Advisory/Consultancy, Acted as consultant (not compensated) : AstraZeneca; Research grant/Funding (institution): Eli Lilly; Advisory/Consultancy, Acted as consultant (not compensated): BMS. K. Peterson: Honoraria (self): Eli Lilly ; Honoraria (self), Travel/Accommodation/Expenses: Genentech; Advisory/Consultancy, Travel/Accommodation/Expenses: Foundation Medicine; Travel/Accommodation/Expenses: Nektar. A. Prat: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Spouse/Financial dependant, family member is an employee : Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (self): MSD Oncology; Honoraria (self): Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Boehringer; Advisory/Consultancy, Research grant/Funding (institution): Puma; Advisory/Consultancy: Oncolytics Biotech; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Nanostring Technologies; Research grant/Funding (institution): Incyte. D. Tripathy: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: Nektar; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Sellas Life Sciences; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Genomic Health; Advisory/Consultancy, Research grant/Funding (institution): Polyphor. B. Xu: Advisory/Consultancy: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy: Pfizer; Speaker Bureau/Expert testimony: Eisai. D.A. Yardley: Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (institution), Research grant/Funding (institution): Genentech; Advisory/Consultancy: Immunomedics, Inc.; Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution), Research grant/Funding (institution): Odonate Therapeutics; Honoraria (institution): R-Pharm US; Honoraria (institution): Seattle Genetics; Research grant/Funding (institution): AbbVie; Research grant/Funding (institution): Dana-Farber Cancer Institute; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): G1 Therapeutics; Research grant/Funding (institution): MacroGenics; Research grant/Funding (institution): Medivation; Research grant/Funding (institution): NSABP; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): US Oncology. D. Mills: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. G. Klauss: Travel/Accommodation/Expenses, Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis. C. Wong: Shareholder/Stockholder/Stock options, Full/Part-time employment, Patents, royalties, other intellectual property: Novartis. F. André: Research grant/Funding (institution): Novartis; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Roche.