Q4 2021 Results
Participants
Financial performance
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors Hematology
Biosimilars
Global Health
Abbreviations
PiqrayⓇ
-
PI3K-alpha inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
NCT04729387 EPIK-O (CBYL719K12301)
Ovarian Cancer
Phase 3
358
Progression Free Survival (PFS) based on Blinded Independent Review Committee
(BIRC) assessment using RECIST 1.1 criteria
Arm 1 Experimental: Alpelisib+olaparib: Alpelisib 200 mg orally once daily and
olaparib 200 mg orally twice daily on a continuous dosing schedule
Arm 2 Active Comparator: Paclitaxel or PLD. Investigator's choice of one of 2 single
agent cytotoxic chemotherapies: Paclitaxel 80 mg/m2 intravenously weekly or
Pegylated liposomal Doxorubicin (PLD) 40-50 mg/m2 (physician discretion)
intravenously every 28 days.
Patients with platinum resistant or refractory high-grade serous ovarian cancer, with
no germline BRCA mutation detected
Read-out Milestone(s)
2023
Publication
TBD
122 Investor Relations | Q4 2021 Results
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