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Novartis Q4 Results

Content Click below to navigate through the document ScemblixⓇ: ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results INNOVATION ↓ ↑ 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 13
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