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How effective is Verzenio?

Medically reviewed by Carmen Fookes, BPharm. Last updated on Nov 12, 2021.

Official answer

by Drugs.com
  • Verzenio plus endocrine therapy (ET) decreased the risk of breast cancer recurrence and death by 37% and showed an absolute benefit in invasive disease-free survival (IDFS) rate of 7.1% at 3 years in men and women with early breast cancer and high-risk clinical and pathological factors and a Ki-67 score ≥20%.
  • Women taking Verzenio plus aromatase inhibitors experienced a longer progression-free survival than those taking 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 on 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-) early breast cancer who have high-risk clinical and pathological factors and a Ki-67 score ≥20%, and HR+ HER2- advanced or metastatic breast cancer in men or women. It 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 that for men or women with early breast cancer and high-risk clinical and pathological factors and a Ki-67 score ≥20% taking Verzenio plus tamoxifen or ET:

  • There was a statistically significant improvement in invasive disease free survival for this pre-specified subgroup of patients 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 placebo.

For women taking Verzenio in combination with fulvestrant:

  • Fewer women experienced an “event” that impacted on 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- 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.

It is also approved to treat adults with early breast cancer at high risk of recurrence and a Ki 67 score of at least 20% (by FDA approved test) in combination with endocrine treatment (tamoxifen or an aromatase inhibitor).

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