NICE Draft Guidelines Recommend Eli Lilly's Verzenios for HR+/HER2- Metastatic Breast Cancer

Compiled and translated | Tom Li

Recently, draft NICE guidance has recommended Eli Lilly’s Verzenios (abemaciclib), administered orally twice daily, for the treatment of adult patients with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body.

In February this year, the UK cost-effectiveness regulatory agency rejected the application for Verzenios, citing a lack of direct evidence to establish its comparative efficacy versus exemestane in combination with everolimus, with the regulator noting uncertainty surrounding the efficacy of Verzenios combined with fulvestrant. Currently, the standard of care for patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer following prior endocrine therapy involves treatment with exemestane in combination with endocrine therapy.

In a new statement, NICE stated that the newly issued positive recommendation for Verzenios was made following improvements to Eli Lilly’s patient access scheme and the submission of additional economic modeling data. Having determined that the therapy is cost-effective, NICE can now recommend Verzenios for routine use within the UK’s National Health Service (NHS). The draft guidance published by NICE also means that Verzenios will now transition out of the Cancer Drugs Fund and, as an NHS-commissioned medicine, will be routinely available to eligible patients. NICE stated that following the recommendation, approximately 2,500 patients are expected to be eligible for treatment with Verzenios.

Verzenios is a CDK4/6 inhibitor that selectively inhibits cyclin-dependent kinase 4/6 (CDK4/6), restoring cell cycle control and blocking tumor cell proliferation. CDK4/6 are key regulators of the cell cycle, triggering the transition from the growth phase (G1 phase) to the DNA synthesis phase (S phase). In estrogen receptor-positive (ER+) breast cancer, CDK4/6 hyperactivation is highly prevalent, and CDK4/6 serves as a key downstream target of ER signaling. This medication can be used in combination with the endocrine therapy agent fulvestrant for adult patients who have previously received endocrine therapy.

In this regard, Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, stated that advanced breast cancer is an incurable disease, and the goal of treatment is to delay disease progression and prolong survival. The committee believes that CDK4/6 inhibitors such as Verzenios will be welcomed by patients, as the drug can delay disease progression, thereby postponing or avoiding the need for chemotherapy.

Last June, Eli Lilly announced positive results from the Phase III monarchE trial evaluating the targeted anticancer drug Verzenio (abemaciclib) for breast cancer. Conducted in patients with high-risk, node-positive, HR+/HER2– early breast cancer, the study met its primary endpoint of invasive disease-free survival (IDFS). Compared with standard adjuvant endocrine therapy (ET), Verzenio in combination with standard adjuvant ET significantly reduced the risk of breast cancer recurrence or death. NICE is expected to publish final guidelines this September on the use of Verzenios in combination with fulvestrant for hormone receptor-positive, HER2-negative metastatic breast cancer.

Source: NICE recommends Eli Lilly’s breast cancer drug Verzenios