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 MedicineView entire presentation