Eli Lilly’s Early Breast Cancer Drug Gets FDA Nod but Faces Tricky Rollout

The FDA has approved Eli Lilly’s Verzenio (abemaciclib) to treat patients with a specific type of early breast cancer in the adjuvant setting. However, the first-in-class approval comes with a big restriction that only patients at high risk of recurrence are eligible.

Verzenio, a CDK4/6 inhibitor that disrupts the cancer cell cycle, will be paired with endocrine (hormone) therapy to treat patients who test positive for hormone receptor (HR+) but negative for human epidermal growth factor receptor 2 (HER2-). The important caveat is that patients must also have a Ki-67 score exceeding or equal to 20%.

The Ki-67 assessment tests the growth rate of cancer cells through a staining process. The higher the score, the more quickly the cancer cells are dividing, which indicates a faster-growing, more aggressive cancer. Scores less than 10% are considered low, while those exceeding 20% would put the patient in the “high risk” category where their cancer has a high chance of returning.

Lilly’s drug is the first CDK4/6 inhibitor approved for this type of early breast cancer. It is also the first FDA-approved addition to adjuvant endocrine therapy in nearly two decades for this setting.

Jacob Van Naarden, President of Lilly Oncology, said the company is “pleased with this initial approval in the adjuvant setting” and hopes that the use of Verzenio in the early breast cancer setting can be expanded “as these data continue to mature.”

“Women and men living with high-risk HR+ HER2- early breast cancer want to do all they can to reduce the risk of the disease coming back, with the hope of living free of cancer. The approval of Verzenio provides a new treatment option to help them do just that,” said Jean Sachs, CEO of Living Beyond Breast Cancer, a nonprofit. “This approval brings new optimism to the breast cancer community.”

Verzenio Improves Patient Survival in Phase 3 Study

Verzenio’s approval is based on efficacy results from a subgroup analysis in Phase 3 monarchE study. The randomized open-label study enrolled patients with HR+, HER2- early breast cancer with a high risk of cancer recurrence.

The primary endpoint of the study of invasive disease-free survival (IDFS) was met at a prespecified interim analysis. Overall, the group treated with Verzenio plus endocrine therapy (ET) had statistically significant improvement in IDFS compared to the placebo group treated with ET alone.

A subgroup analysis was subsequently carried out in 2003 patients with a collection of high-risk clinical and pathological factors and a Ki-67 score≥20%. The results showed this subgroup also had improved IDFS following treatment with Verzenio compared to placebo. The drug decreased the risk of death or recurrence by as much as 37% compared to the standard of care group.

Data supporting this approval will be presented at the October 14 European Society for Medical Oncology (ESMO) Virtual Plenary.

Lilly Leaps Ahead of Rivals 

Despite Verzenio being FDA-approved two years later than Pfizer’s Ibrance and half a year later than Novartis’ Kisqali for metastatic breast cancer, Lilly has caught up to the competition with the success of its MonarchE study and the subsequent approval in the early breast cancer setting.

On the other hand, in contrast to its glowing sales exceeding $5 billion in 2020, Pfizer’s drug crashed hard in two Phase 3 trials (dubbed Penelope-B and Pallas) in the early breast cancer setting.

Meanwhile, Novartis’ Kisqali is awaiting data on its own trial in the same setting, which won’t be available until late 2022.

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Joy Lin

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