New Medicines

Verzenios (EU), Verzenio (US)Breast cancer - adjuvant therapy


Verzenios (EU), Verzenio (US)
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
Feb 22EU positive opinion granted recommending a licence change to include use for treatment of early breast cancer (previously licensed only for treatment of advanced or metastatic breast cancer). The proposed new indication is “Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, node‑positive early breast cancer at high risk of recurrence. In pre‑ or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist" [11].
Oct 21FDA has approved abemaciclib (in combination with tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with HR+ HER2-, node positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test [9].
Mar 21Currently pre-registration - presume has been filed in the EU and US [8].
Dec 20Lilly will submit the monarchE data to regulatory authorities before the end of 2020.[7].


CDK4/6 inhibitor
In 2012, there were 51,103 new cases of breast cancer in the UK: 50,750 (99%) in women and 353 (1%) in men. The crude incidence is 157/100,000 females, and 1/100,000 males. More people with a known stage are diagnosed at an early stage (84% diagnosed at stage I or II) than an advanced stage (16% diagnosed at stage III or IV). More than 1 in 20 (6%) people have metastases at diagnosis (stage IV) [1].
Breast cancer - adjuvant therapy

Further information


Trial or other data

Oct 21PIII open-label trial (NCT03155997; n=5637) found invasive disease-free survival benefit was maintained after median 27 months (HR 0.70 vs endocrine therapy alone; 95% CI 0.59-0.82; P<0.0001); regardless of Ki-67 index [10].
Dec 20Eli Lilly announces additional data from a pre-planned primary outcome analysis from the monarchE trial that showed abemaciclib in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). This statistically significant improvement corresponds to a three percent difference in the two-year rate of invasive disease-free survival (IDFS) between arms (92.3 percent in the Verzenio arm and 89.3 percent in the control arm). The addition of Verzenio to ET also resulted in an improvement in distant relapse-free survival (DRFS), or time to developing breast cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 31.3 percent compared to 28.3 percent at interim analysis (HR: 0.687; 95% CI: 0.551, 0.858). Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed. Compared to the interim analysis results, there were minimal increases in adverse events [7].
Sep 20At a preplanned efficacy interim analysis of the PIII monarchE study (n=5,637), abemaciclib plus endocrine therapy (ET) demonstrated superior invasive disease-free survival vs ET alone (hazard ratio, 0.75; 95% CI, 0.60 to 0.93, p=0.01) [6].
Jun 20Interim analysis of PIII monarchE study (n=5367) finds primary endpoint of invasive disease-free survival is met. Eli Lilly plan to submit applications to regulatory authorities before end of 2020 [5].
Dec 19PIII monarchE study (NCT03155997) has finished recruiting; timescales unchanged [4].
Nov 18PIII monarchE study (NCT03155997) is still recruiting. 4,580 patients are now expected to be recruited, and collection of primary outcome data expected earlier in Apr 21 [3].
Jul 17PIII monarchE study (NCT03155997) starts. The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. 3,580 patients will be recruited from sites worldwide including US & EU (plus UK). Primary outcome is invasive disease free survival; collection of these data is expected to complete Jun 22 [2].

Evidence based evaluations