期刊
FUTURE ONCOLOGY
卷 18, 期 31, 页码 3481-3492出版社
FUTURE MEDICINE LTD
DOI: 10.2217/fon-2022-0666
关键词
alpelisib; chemotherapy; high-grade serous ovarian cancer; olaparib; ovarian cancer; PARP inhibitor; PI3K inhibitor
类别
资金
- Novartis Pharmaceuticals Corporation
- Breast Cancer Research Foundation
- Stand Up To PI3K Cancer Dream Team Translational Research Grant [SU2C-AACR-DT0209]
- Stand Up To Cancer/Ovarian Cancer Research Fund Alliance/National Ovarian Cancer Coalition Ovarian Cancer Dream Team Translational Research Grant [SU2C-AACR-DT16-15]
- NCI [P50CA240243]
- Novartis
- AstraZeneca
- Beigene
- Boehringer Ingelheim
- Lilly/Ignyta
- Clovis Oncology
- GSK
- PharmaMar
- MSD
This article describes a study investigating the combination of the specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib and the poly (adenosine diphosphateribose) polymerase (PARP) inhibitor olaparib in platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) patients without germline BRCA mutation. The study aims to improve the prognosis of patients with this condition.
Patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) have a poor prognosis, and their management represents a substantial unmet medical need. Preclinical data and results from a phase lb trial demonstrated the efficacy and tolerability of the combination of the << specific phosphatidylinositol-3-kinase (P13K) inhibitor alpelisib plus the poly (adenosine diphosphateribose) polymerase (PARP) inhibitor olaparib in platinum-resistant, non-BRCA-mutated ovarian cancer. Here, we describe the study design and rationale for the phase III, multicenter, open-label, randomized, active-controlled EPIK-O/ENGOT-OV61 trial investigating alpelisib in combination with olaparib compared with standard-of-care chemotherapy in patients with platinum-resistant or -refractory HGSOC with no germline BRCA mutation. Progression-free survival (blinded independent review committee) is the primary end point. Overall survival is a key secondary end point.
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