Q3 2023 Results
Company overview
Financial review
Conclusions
Appendix
References
INNOVATION
Kisqali® Ph3 NATALEE IDFS 500 event analysis complete,
US submission planned for Q4 2023; file submitted in EU
KISQALI
Ph3 NATALEE results as presented at ASCO 20231
Second interim efficacy analysis at 426 iDFS events
HR
95% CI
IDFS total population
0.75
(0.62, 0.91)
IDFS-stage II
0.76
(0.53, 1.10)
iDFS - stage III
0.74
(0.59, 0.92)
iDFS node negative
0.63
(0.34, 1.16)
iDFS node positive
0.77
(0.63, 0.94)
RFS
0.72
(0.58, 0.88)
DDFS
0.74
(0.60, 0.91)
OS
0.76
(0.54, 1.07)
ESMO 2023 updates
Consistent iDFS benefit² across subgroups: stage,
menopausal status, age, nodal status
Good tolerability profile³: addition of KisqaliⓇ to
ET did not compromise patients' QoL on any of the
scales evaluated
Regulatory status / next steps
Filed in Europe
500 iDFS event milestone reached; data consistent
with interim analysis (March 20234)
US submission planned for Q4 2023
1. Interim analysis. Slamon D, Stroyakovskiy D, Yardley D, et al. Ribociclib and endocrine therapy as adjuvant treatment in patients with HR+/HER2- early breast cancer. 2. Slamon D, et al. ASCO 2023. LBA500 [Oral].
3. Fasching PA, et al. ESMO 2023 Virtual Plenary. Oral VP3-2023. 4. Interim analysis in March 2023, data presented at ASCO 2023.
10 Investor Relations | Q3 2023 Results
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