Eli Lilly Verzenio reduces the recurrence risk of breast Cancer by 38.6%!

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Eli Lilly Verzenio reduces the recurrence risk of breast Cancer by 38.6%!

Eli Lilly Verzenio reduces the recurrence risk of breast Cancer by 38.6%!  New breast cancer drug! Eli Lilly’s Verzenio (Vision®) + endocrine therapy HR+/HER2-early breast cancer after neoadjuvant chemotherapy: reduce the risk of recurrence by 38.6%!

Eli Lilly recently announced the evaluation of the targeted anticancer drug Verzenio (trade name: Weize®, generic name: abemaciclib, abemaciclib) combined with standard adjuvant endocrine therapy (ET) and single standard adjuvant ET regimen treatment Data from an exploratory analysis of the HR+/HER2-High-risk Early Breast Cancer (EBC) Phase III monarchE study.

The results showed that in the subgroup of HR+/HER2-high-risk EBC patients who received neoadjuvant chemotherapy, Verzenio+ET reduced the risk of breast cancer recurrence by 38.6% compared with ET.

Breast cancer is the most common cancer among women worldwide. It is estimated that 90% of breast cancers are diagnosed at an early stage. About 70% of breast cancers are HR+/HER2-, which is the most common subtype. Even in the HR+/HER2- subtype, breast cancer is a complex disease, and many factors-such as whether the cancer has spread to the lymph nodes, the biological characteristics of the tumor-will affect the risk of recurrence.

Patients receiving neoadjuvant chemotherapy usually represent a group of patients with a very high risk of recurrence. New data from the monarchE study further confirms this higher risk, as the control group in this subgroup of patients experienced a greater number of relapse events. Considering the need for new treatments for high-risk EBC, especially in the neoadjuvant treatment population, adding Verzenio to the standard ET regimen reduces the risk of recurrence by 38%. These data are impressive and encouraging.

monarchE is a multi-center, randomized, open-label phase 3 trial that enrolled 5637 hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2- ), lymph node-positive, high-risk early breast cancer (eBC) patients. In the study, patients were randomly divided into 2 groups at 1:1 and received Verzenio (150 mg, twice a day) combined with standard adjuvant endocrine therapy (ET) and standard adjuvant ET. The patient receives treatment for 2 years (treatment period) or until the discontinuation criterion is reached. After the treatment period is over, all patients will continue to receive ET treatment for 5-10 years.

In an exploratory analysis, compared with the intention-to-treat (ITT) population (n=5673), standard adjuvant ET combined with Verzenio produced a pre-specified subgroup of patients who received neoadjuvant chemotherapy (n=2056) Greater impact. This subgroup of patients accounted for more than 36% of the total trial population. At the time of initial diagnosis, the tumor was larger and more common before menopause. It is one of the highest-risk subgroups of patients in the monarchE trial.

The specific data are: Compared with standard auxiliary ET alone, Verzenio combined with standard auxiliary ET reduced the risk of breast cancer recurrence by 38.6% (HR=0.614; 95%CI: 0.473, 0.797). The difference in the 2-year IDFS between the two treatment groups was 6.6% (87.2% in the Verzenio+ET group and 80.6% in the ET group).

In addition, compared with ET, Verzenio+ET reduced the risk of metastatic disease by 39% (HR=0.609; 95%CI: 0.459, 0.809). The difference in 2-year remote recurrence-free survival (DRFS) between the two treatment groups was 6.7% (89.5% in the Verzenio+ET group and 82.8% in the ET group). The safety data in this test is consistent with the known safety features of Verzenio, and no new safety signals have been observed.

These data are based on the main results of the Phase 3 monarchE trial: the trial had reached the primary endpoint in the second interim analysis, showing a statistically significant improvement in iDFS. Compared with ET, Verzenio+ET reduced the risk of breast cancer recurrence by 28.7% (HR=0.713; 95%CI: 0.583, 0.871; p=0.0009), and the absolute difference in the 2-year IDFS and DRFS rates among the ITT population was 3% . The trial is ongoing, and patients will continue to be followed to assess safety, overall survival (OS), patient-reported results, and other endpoints.

The active pharmaceutical ingredient of Verzenio is abemaciclib, which is an oral targeted CDK4/6 inhibitor that can selectively inhibit cyclin-dependent kinase 4/6 (CDK4/6), restore cell cycle control, and block tumor cells proliferation. Uncontrolled cell cycle is a hallmark of cancer. CDK4/6 is overactive in many cancers, leading to uncontrolled cell proliferation.

CDK4/6 is a key regulator of the cell cycle, which can trigger the transition of the cell cycle from the growth phase (G1 phase) to the DNA replication phase (S1 phase). In estrogen receptor positive (ER+) breast cancer, the overactivity of CDK4/6 is very frequent, and CDK4/6 is a key downstream target of ER signaling.

Preclinical data shows that dual inhibition of CDK4/6 and ER signaling has a synergistic effect and can inhibit the growth of ER+ breast cancer cells in G1 phase. Clinical evidence also shows that abemaciclib crosses the blood-brain barrier. In advanced cancer patients, including breast cancer patients, the concentration of abemaciclib and its active metabolites (M2 and M20) in the cerebrospinal fluid is equivalent to the unbound plasma concentration.

Verzenio was approved for marketing in October 2017 for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer. The drug is suitable for: (1) Combined with an aromatase inhibitor (AI) as the initial endocrine therapy for the treatment of postmenopausal women (2) Combined with fulvestrant for women who have progressed in endocrine therapy; (3) As a monotherapy, it is used in adult patients who have received endocrine therapy and chemotherapy to control metastatic disease but have progressed.

At present, there are many CDK4/6 inhibitors on the market, in addition to Eli Lilly’s Verzenio, Pfizer’s Ibrance (palbociclib) and Novartis’s Kisqali (ribociclib).  The drug indications are : Combined with aromatase inhibitor, as an initial endocrine therapy for the treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer.

Eli Lilly Verzenio (trade name: Weize®, generic name: abemaciclib, abexili) is used to treat HR+/HER2- locally advanced or metastatic breast cancer:

(1) Use in combination with aromatase inhibitors as the initial endocrine therapy for postmenopausal female patients;

(2) It is used in combination with Fulvestrant for patients who have experienced disease progression after receiving endocrine therapy.

(source:internet, reference only)

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