Q3 2021 Investor Relations Results slide image

Q3 2021 Investor Relations Results

Participants Company overview Pharmaceuticals Oncology Financial review Conclusion Appendix References 3 INNOVATION Kisqali® is being investigated in HR+/HER2- early breast cancer (adjuvant) in the Ph3 NATALEE study, expected readout in 2022 NATALEE study design Primary endpoint: invasive disease-free survival (iDFS), event driven Sample size increased to 5000 - more robust RIB Ribociclib 400 mg/day, 3 weeks on/1 week off, 36 months (~ 39 cycles) 36 months Early Breast Cancer (EBC) ■ 83% of breast cancers are diagnosed as EBC ■ EBC treatment objective: cure the patient by preventing disease recurrence while maintaining QoL What makes NATALEE unique? ■ Includes patients with high and intermediate risk of recurrence based on AJCC prognostic staging HR+/HER2- + EBC Pre- and post- R 1:1 ET menopausal Anatomic Stage II & III 20 Investor Relations | Q3 2021 Results ET 60 months NSAI 60 months [+goserelin in pre-menopausal women & men] 60 months NSAI 60 months [+goserelin in pre-menopausal women & men] ■ Longer treatment duration: 3 vs. 2 years ■ Lower dose compared to metastatic setting (400 vs. 600mg) may improve overall tolerability Study status ■ Enrollment complete; readout event-driven and expected late 2022; planned submission 2023 ■ FDA feedback confirms iDFS acceptable as primary analysis provided no detriment in OS NOVARTIS | Reimagining Medicine
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