Novartis Q4 Results
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VijoiceⓇ - PI3Ki
Company overview
NCT05948943 EPIK-L1 (CBYL719P12201)
Indication
Financial review
Phase
Conclusions
Appendix
Innovation: Pipeline overview
Financial performance
Innovation: Clinical trials
Cardiovascular, Renal
and Metabolic
Immunology
Neuroscience
> Oncology
Other
Global Health
Abbreviations
Patients
Primary Outcome
Measures
Arms Intervention
Lymphatic Malformation
Phase 2/3
230
Stage 2: Radiological response rate at Week 24 of Stage 2 (adult and pediatric (6 - 17 years of
age) participants)
Time Frame: Baseline, Week 24
Arm 1: Experimental. Adult participants, alpelisib dose 1 (Stage 1)
Arm 2: Experimental. Adult participants, alpelisib dose 2 (Stage 1)
Arm 3: Experimental. Pediatric participants (6-17 years of age), alpelisib dose 2 (Stage 1)
Arm 4: Experimental. Pediatric participants (6-17 years of age), alpelisib dose 3 (Stage 1)
Arm 5: Experimental. Adult participants, alpelisib (Stage 2)
Arm 6: Placebo comparator. Adult participants, placebo (Stage 2)
Arm 7: Experimental. Pediatric participants (6-17 years of age), alpelisib (Stage 2)
Arm 8: Placebo Comparator. Pediatric participants (6-17 years of age), placebo (Stage 2)
Arm 9: Experimental. Pediatric participants (2-5 years of age), alpelisib (Stage 2)
Pediatric and adult patients with lymphatic malformations associated with a PIK3CA mutation
References
Target Patients
Readout
2030
Milestone(s)
Publication
TBD
□ NOVARTIS Reimagining Medicine
Novartis Q4 Results | January 31, 2024
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