Q1 2022 Results
Company overview
CRM
Financial performance
Immunology
PiqrayⓇ
-
Financial review
Neuroscience
2022 priorities
Innovation: Pipeline overview
Ophthalmology
Appendix
References
Innovation: Clinical trials
Abbreviations
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
PI3K-alpha inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
NCT04208178 EPIK-B2 (CBYL719G12301)
HER-2 positive breast cancer
Phase 3
548
Progression-free survival (PFS)
Alpelisib + trastuzumab + pertuzumab
Trastuzumab + pertuzumab
Target Patients
Patients with HER2-positive advanced breast cancer with a PIK3CA mutation
Read-out Milestone(s)
2025
Publication
TBD
NCT04251533 EPIK-B3 (CBYL719H12301)
Triple negative breast cancer
Phase 3
566
Progression-free Survival (PFS) for patients with PIK3CA mutant status
Alpelisib 300 mg + nab-paclitaxel 100 mg/m²
Placebo nab-paclitaxel 100 mg/m²
Patients with advanced triple negative breast cancer with either Phosphoinositide-3-
kinase Catalytic Subunit Alpha (PIK3CA) mutation or Phosphatase and Tensin
Homolog Protein (PTEN) loss without PIK3CA mutation
2023
TBD
96 Investor Relations | Q1 2022 Results
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