• Verzenio plus endocrine therapy (ET) decreases the risk of breast cancer recurrence by 35% compared to ET alone. 4-year data from the monarchE trial showed 85.5% of patients remained recurrence-free after 4 years compared to 78.6% of those assigned ET alone (an absolute difference of 6.9%).
• Women taking Verzenio plus an aromatase inhibitor experienced a longer progression-free survival than those taking a placebo (28.2 months compared to 14.8 months).
• 55% of women experienced a complete or partial response to Verzenio plus an aromatase inhibitor.
• Women taking Verzenio plus fulvestrant were less likely to experience an “event” that impacted their disease progression (49.8% vs 70.4%).
• For women taking Verzenio as monotherapy, 19.7% saw their tumors shrink by 30% or more.

Verzenio (abemaciclib) is a targeted treatment that helps to reduce the growth and spread of cancer cells in the body. It may be used to treat men or women with hormone receptor-positive, HER2-negative (HR+ HER2-), node-positive, early breast cancer at high risk of recurrence. It is also approved for HR+ HER2- advanced or metastatic breast cancer in men or women. Verzenio may be given when cancer has progressed or spread to other parts of the body after treatments such as anti-estrogens or chemotherapy have already been given.

Verzenio belongs to the class of medicines known as CDK 4/6 inhibitors which help to reduce the growth and spread of cancer cells in the body.

Clinical trials have shown favorable results for men or women with early breast cancer and high-risk clinical and pathological factors taking Verzenio plus tamoxifen or ET.

• There was a deepened benefit in invasive disease-free survival in those taking Verzenio in combination with ET compared to those taking ET alone, in a follow-up of the monarchE trial at 4 years compared to the results seen at 2 years. 85.5% of patients remained recurrence-free after 4 years compared to 78.6% of those assigned ET alone (an absolute difference of 6.9%). At 2 years the absolute difference was 3.1% and at 3 years it was 5.0%. Verzenio plus ET reduces the risk of recurrence by 35% compared to ET alone.
• There was a statistically significant improvement in invasive disease-free survival for a pre-specified subgroup of patients (those with a Ki-67 score ≥20%) receiving Verzenio plus endocrine therapy (ET) compared to those who received ET alone (HR=0.643, 95% CI: 0.475, 0.872, p=0.0042)
• There was a 37% decrease in the risk of breast cancer recurrence or death compared to standard ET therapy alone (HR: 0.626 [95% CI: 0.49-0.80])
• An absolute benefit in invasive disease-free survival (IDFS) rate of 7.1% was reported at three years
• Preliminary results reported the number of IDFS events at the time of publication was 104 with Verzenio plus ET compared to 158 with ET alone.

For women taking Verzenio plus anastrozole or letrozole:

• Progression-free survival (the length of time without a worsening of their breast cancer) was longer with Verzenio: 28.2 months for women taking the Verzenio combination compared with 14.8 months for women taking the placebo combination
• 55.4% of women taking the Verzenio combination had either a complete response or a partial response compared to only 40.2% taking a placebo.

For women taking Verzenio in combination with fulvestrant:

• Fewer women experienced an “event” that impacted their progression-free survival: 49.8% of women taking Verzenio experienced an event compared to 70.4% of those taking the placebo combination
• Overall survival was 46.7 months in women taking the Verzenio combination compared with 37.3 months in those taking the placebo combination
• 48.1% of women responded to the Verzenio combination compared with 21% of women taking the placebo combination.

For women taking Verzenio as monotherapy:

• 19.7% of women saw their tumors shrink by 30% or more
• The average duration of response was 8.6 months.

Verzenio is usually taken twice daily. When taken regularly, consistent blood levels are achieved within five days. Gastrointestinal side effects, such as diarrhea, typically occur in the first month of treatment and can affect up to 81% of patients. The average time to onset of diarrhea was 6 to 8 days. Diarrhea can be severe and requires monitoring and proper management.

Who can use Verzenio?

Verzenio is indicated for the treatment of HR+ HER2- early breast cancer at high risk of recurrence in combination with endocrine treatment (tamoxifen or an aromatase inhibitor). It may also be used to treat HR+ HER2- advanced or metastatic breast cancer:

• in combination with an aromatase inhibitor for postmenopausal women, and men, as initial endocrine-based therapy
• in combination with fulvestrant for adult patients with disease progression following endocrine therapy
• as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.