Phosphatidylinositol 3-kinase (PI3K) pathway hyperactivation due to
Men/postmenopausal women (N=572) with HR+, HER2– ABC with no prior chemotherapy treatment (tx) and whose disease progressed on/after AI were randomized 1:1 to receive ALP (300 mg PO QD) or PBO, + FUL (500 mg IM on D1 and D15 of C1 then D1 of each 28-d cycle) and stratified by presence of lung and/or liver metastases and prior cyclin-dependent kinase 4/6 inhibitor. OS in the
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;
Though not statistically significant, OS was prolonged by a clinically relevant ≈8 mo with ALP when added to FUL in HR+, HER2−,
NCT02437318.
We thank Rob M. Camp, PhD, of Healthcare Consultancy Group, LLC, for his medical editorial assistance with this abstract, which was funded by Novartis Pharmaceuticals.
Novartis Pharmaceuticals Corporation.
Novartis Pharmaceuticals Corporation.
F. André: Research grant/Funding (institution): Novartis; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Daiichi Sankyo. E.M. Ciruelos: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Eli Lilly; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Honoraria (self): AstraZeneca. D. Juric: Research grant/Funding (self): Novartis; Advisory/Consultancy: Genentech; Advisory/Consultancy: Eisai; Advisory/Consultancy: Ipsen; Advisory/Consultancy: EMD Serono. S. Loibl: Honoraria (institution), Research grant/Funding (institution): Novartis; Honoraria (institution), Research grant/Funding (institution): Pfizer; Honoraria (institution), Research grant/Funding (institution): Celgene; Honoraria (institution), Research grant/Funding (institution): Amgen; Honoraria (institution), Research grant/Funding (institution): Roche; Honoraria (institution), Research grant/Funding (institution): AstraZeneca; Honoraria (institution), Research grant/Funding (institution): AbbVie; Honoraria (institution): Eli Lilly; Honoraria (institution), Research grant/Funding (institution): Daiichi-Sankyo; Honoraria (institution): Eirgenix; Honoraria (institution): Seattle Genetics; Honoraria (institution): PriME/ Medscape; Honoraria (self): Chugai; Research grant/Funding (institution): Teva; Research grant/Funding (institution): Vifor; Honoraria (institution): Samsung; Honoraria (institution): Bristol-Myers Squibb; Honoraria (institution): Puma; Honoraria (institution): MSD; Research grant/Funding (institution): Immunomedics. M. Campone: Research grant/Funding (institution), Non-remunerated activity/ies: Novartis; Honoraria (self), Research grant/Funding (institution): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Advisory/Consultancy: Servier; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Accord; Research grant/Funding (institution): Tesaro; Advisory/Consultancy: Eli Lilly. I. Mayer: Advisory/Consultancy, Research grant/Funding (institution): Novartis; Advisory/Consultancy, Research grant/Funding (institution): Genentech; Advisory/Consultancy: Eli Lilly; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GlaxoSmithKline; Advisory/Consultancy: Immunomedics; Advisory/Consultancy: Macrogenics; Advisory/Consultancy: Seattle Genetics; Research grant/Funding (institution): Pfizer; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Puma. G. Rubovszky: Honoraria (self): Novartis. T. Yamashita: Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self): Eisai; Honoraria (self): Novartis; Honoraria (self): Taiho; Honoraria (self), Research grant/Funding (institution): Nippon Kayaku; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Kyowa Kirin; Honoraria (self): Pfizer Japan; Honoraria (self): Eli Lilly; Honoraria (self): Daiichi Sankyo. B. Kaufman: Honoraria (self): Novartis; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): AbbVie. Y-S. Lu: Advisory/Consultancy, Speaker Bureau/Expert testimony, Clinical study trial fee: Novartis; Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Advisory/Consultancy: Boehringer Ingelheim; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Merck Sharp & Dohme; Research grant/Funding (institution): GlaxoSmithKline. K. Inoue: Research grant/Funding (institution): Novartis; Honoraria (self), Research grant/Funding (institution): Pfizer; Honoraria (self), Research grant/Funding (institution): Chugai; Honoraria (self), Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): Daiichi-Sankyo; Research grant/Funding (institution): Parexel/Puma Biotechnology; Research grant/Funding (institution): MSD; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Sanofi. M. Takahashi: Honoraria (self): Novartis; Honoraria (self): AstraZeneca; Honoraria (self), Research grant/Funding (institution): Eisai; Honoraria (self): Eli Lilly; Honoraria (self): Pfizer; Research grant/Funding (institution): Chugai; Research grant/Funding (institution): Nippon Kayaku; Research grant/Funding (institution): Taiho. F. Ghaznawi: Full/Part-time employment: Novartis Pharmaceuticals Corporation. D. Mills: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis Pharma AG. M. Kaper, M. Miller: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis Pharmaceuticals Corporation. P.F. Conte: Speaker Bureau/Expert testimony: Genenetech/Roche; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (institution): Roche; Research grant/Funding (institution): Merck Serono; Travel/Accommodation/Expenses: Celgene. H. Iwata: Honoraria (self), Advisory/Consultancy: Daiichi-Sankyo; Honoraria (self), Advisory/Consultancy: Chugai/Roche; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Non-remunerated activity/ies, Uncompensated member of the steering committee for the SOLAR-1 trial: Novartis; Honoraria (self), Advisory/Consultancy: Eli Lilly; Honoraria (self): Eisai; Honoraria (self): Taiho; Advisory/Consultancy: AbbVie; Advisory/Consultancy: Odonate; Advisory/Consultancy: Kyowa Hako Kirin; Honoraria (self), Advisory/Consultancy: AstraZeneca. H.S. Rugo: Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; 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), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (institution): Immunomedics; Advisory/Consultancy: Samsung; Advisory/Consultancy: Puma; Travel/Accommodation/Expenses: AstraZeneca; Research grant/Funding (institution): Sermonix; Research grant/Funding (institution): Seattle Genetics. All other authors have declared no conflicts of interest.