Data from Pharmawand - Curated by EPG Health - Date added 19 December 2018

Eli Lilly and Company announced npj Breast Cancer published results from exploratory subgroup analyses of the MONARCH 2 and MONARCH 3 trials reinforcing the clinical benefit of Verzenio (abemaciclib) plus endocrine therapy in the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

The analyses demonstrate that while the benefit of the addition of Verzenio was seen across all patient subgroups, consistent with the individual study intent-to-treat (ITT) populations, the largest effects were observed in patients with certain disease characteristics identified as signaling a less favorable prognosis.

These exploratory post-hoc analyses pooled data from over 1,000 patients and employed a two-step approach: first, the identification of independent prognostic variables derived from the entire population regardless of treatment assignment, and second, the description of the treatment effect of endocrine monotherapy compared to endocrine therapy plus Verzenio in each of the identified prognostic subgroups within the respective studies. Across both studies, certain prognostic factors included cancer that had spread to the liver (liver metastases), cancer that was not confined to the bone, cancer cells that were dividing more quickly (high tumor grade), and cancer cells that did not express progesterone receptors (PRs) and therefore were less likely to respond to hormonal therapy (PR-negative).

The exploratory analyses concluded that while the benefit of the addition of Verzenio was seen across all patient subgroups, consistent with the individual study ITT populations, patients with poor prognostic factors received the largest benefit from the addition of Verzenio to endocrine therapy. In particular, patients with cancer that spread to the liver, PR-negative tumors, or cancer cells that divided more quickly consistently received a substantial benefit with Verzenio, with a greater than 30 percent difference in response rates. Additionally, in MONARCH 3, the exploratory Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of treatment-free interval (TFI), or how quickly the cancer returned after the completion of adjuvant endocrine therapy, showed those whose cancer returned quickly after the conclusion of adjuvant endocrine therapy derived larger benefit from the addition of Verzenio compared to endocrine therapy alone.

The subgroup analyses are hypothesis-generating and require additional evaluation in prospective clinical trials, but provide the groundwork for considering and investigating more personalized therapy in HR+, HER2- metastatic breast cancer. Lilly is committed to continuing research aimed at helping oncologists optimize care for women with advanced disease.

See- "Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy"- Angelo Di Leo, Joyce O’Shaughnessy[…]Stephen Johnston npj Breast Cancer 4 , 1–8.


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