Novartis Q4 Results
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ScemblixⓇ: ASC4FIRST trial met both primary endpoints with clinically
meaningful and statistically significant results
INNOVATION
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Company overview
Financial review
Conclusions
Appendix
Both primary endpoints met
.
Scemblix shows superior MMR rates at
week 48 vs. SoC TKIs in newly diagnosed
Ph+ CML-CP patients
Favorable safety and tolerability profile with
fewer AEs and treatment discontinuations vs. SoC
TKIs and no new safety signals were observed
Achievement of MMR
BCR-ABL1 ≤ 0.1% is associated with
References
.
●
higher rates of EFS, PFS and OS1
Study design
Primary
endpoint
Week 48
Secondary
endpoint
End of
study
Week 96
5 years
MMR
evaluation
ScemblixⓇ
80mg once-daily
R
N=405
1:1
Investigator-selected TKI
50% 1G TKI: imatinib
50% 2G TKI: nilotinib or dasatinib or bosutinib
Population: Newly diagnosed adult patients with CML-CP with no prior TKI
Primary endpoints as assessed by MMR at 48 weeks: Superiority of ScemblixⓇ vs.
1) investigator choice TKI and/or 2) imatinib subgroup alone
Data will be presented at an upcoming medical congress | CML-CP 1L FDA submission anticipated in H1 2024
CML-CP - chronic myeloid leukemia in chronic phase. MMR - major molecular response (BCR-ABL 1IS ≤0.1%). SoC Standard of care.
al., Leukemia; 34:966-84, 2020.
-
TKI - tyrosine kinase inhibitor. 1. Saussele S et al. Leukemia; 32(5):1222-8; 2018; Hochhaus et
□ NOVARTIS | Reimagining Medicine.
Novartis Q4 Results | January 31, 2024
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