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Verzenios ® (abemaciklib)
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In the MONARCH-2 and MONARCH-3 clinical trials, patients were required to have HR+ disease to be included in the studies.1,2
Patients in the MONARCH-2 and MONARCH-3 studies who were ER- and PR+ are presented in Table 1.
Table 1. ER-/PR+ Patients in the MONARCH-2 and MONARCH-3 Clinical Trials3
|
MONARCH 3 |
MONARCH 2 |
||
Abemaciclib + NSAI |
Placebo + NSAI |
Abemaciclib + Fulvestrant |
Placebo + Fulvestrant |
|
ITT, n |
328 |
165 |
446 |
223 |
ER-/PR+, n |
2 |
0 |
6 |
2 |
Abbreviations: ER- = estrogen receptor-negative; ITT = intent-to-treat; NSAI = nonsteroidal aromatase inhibitor; PR+ = progesterone receptor-positive.
Due to the small number of patients with ER-/PR+ disease, efficacy and safety analyses are not available for this subgroup.
1. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155
2. Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. http://dx.doi.org/10.1200/JCO.2017.73.7585
3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Glossary
ER- = estrogen receptor-negative
HR+ = hormone receptor-positive
PR+ = progesterone receptor-positive
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Datum fӧr senaste ӧversyn 2019 M05 15