In HR +, HER2- MBC *
Even women with worse prognoses achieved survival outcomes consistent with the overall study population 1
WOMEN WITH VISCERAL DISEASE † HAD
8.1 months
longer mOS 1
40.3 months mOS with Verzenio plus fulvestrant ( n = 245 ) vs 32.2 months mOS with fulvestrant alone ( n = 128 ).
WOMEN WITH PRIMARY ET RESISTANCE ‡ HAD
7.2 months
longer mOS 1
38.7 months mOS with Verzenio plus fulvestrant ( n = 112 ) vs 31.5 months mOS with fulvestrant alone ( n = 60 ).
HR = 0.675 ( 95 % CI : 0.511-0.891 )
HR = 0.686 ( 95 % CI : 0.451-1.043 )
• Preplanned subgroup analyses of PFS and OS were performed for stratifi cation factors of disease site ( including visceral disease ) and endocrine resistance ( including primary ET resistance ). Analyses were not adjusted for multiplicity , and the study was not powered to test the effect of Verzenio + fulvestrant among subgroups 11
* With disease progression following ET . † Visceral disease was defi ned as at least 1 lesion on an internal organ or in the third space and could have included lung , liver , pleural , or peritoneal metastatic involvement . 5 ‡ Primary resistance was defi ned as relapse within the fi rst 2 years of adjuvant ET or progressive disease within the fi rst 6 months of fi rst-line ET for MBC . 6 , 7
Important Safety Information ( cont ' d )
Monitor patients for pulmonary symptoms indicative of ILD / pneumonitis . Symptoms may include hypoxia , cough , dyspnea , or interstitial infi ltrates on radiologic exams . Infectious , neoplastic , and other causes for such symptoms should be excluded by means of appropriate investigations .
Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD / pneumonitis . Permanently discontinue Verzenio in all patients with grade 3 or 4 ILD / pneumonitis .
Grade ≥3 increases in alanine aminotransferase ( ALT ) ( 6 % versus 2 %) and aspartate aminotransferase ( AST ) ( 3 % versus 1 %) were reported in the Verzenio and placebo arms , respectively , in MONARCH 3 . Grade ≥3 increases in ALT ( 4 % versus 2 %) and AST ( 2 % versus 3 %) were reported in the Verzenio and placebo arms , respectively , in MONARCH 2 .
In MONARCH 3 , for patients receiving Verzenio plus an aromatase inhibitor with Grade ≥3 increases in ALT or AST , median time to onset was 61 and 71 days , respectively , and median time to resolution to Grade < 3 was 14 and 15 days , respectively . In MONARCH 2 , for patients receiving Verzenio plus fulvestrant with Grade ≥3 increases in ALT or AST , median time to onset was 57 and 185 days , respectively , and median time to resolution to Grade < 3 was 14 and 13 days , respectively .
For assessment of potential hepatotoxicity , monitor liver function tests ( LFTs ) prior to the start of Verzenio therapy , every 2 weeks for the fi rst 2 months , monthly for the next 2 months , and as clinically indicated . Dose interruption , dose reduction , dose discontinuation , or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2 , or Grade 3 or 4 , hepatic transaminase elevation .
Please see Important Safety Information throughout and Brief Summary of full Prescribing Information for Verzenio on the following pages .