Reimagining Medicine
Company overview
Financial review
2023 priorities
Appendix
INNOVATION
KisqaliⓇ - NATALEE study continues following first interim analysis;
final readout expected H2 2023
NATALEE: HR+/HER2- pre- and post-menopausal, early breast cancer Stage II & III | N=5000
R
1:1
3 weeks on/1 week off
36 months
KISQALIⓇ
Endocrine therapy
(NSAI + goserelin³)
Endocrine therapy
(NSAI + goserelin³)
60 months
60 months
Patient population: 218K patients with early breast cancer in US + EU1
NATALEE differentiation
Broad population including anatomical Stage II and III²
Longer treatment duration of 3 vs. 2 years (monarchE)
Lower dose (400mg/day) to potentially improve tolerability and
adherence without compromising efficacy
Study status
Final analysis planned at 500 iDFS events, expected H2 2023
1st interim analysis at 70% of events (completed, study continues)
2nd interim analysis at 85% of events
NSAI - non-steroidal aromatase inhibitor. 1. eBC Patient - Adjuvant Breast Cancer Opportunity Assessment June 2020. 2. Based on AJCC prognostic staging. 60% Stage III and 40% Stage II patients in study. Stage II vs. Stage III is a
stratification factor. The trial did not require Ki-67% or other CDx for patient identification or stratification, but Ki-67% is part of the statistical analysis plan. 3. In pre-menopausal women and in men.
13 Investor Relations | Q4 2022 Results
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