Lilly highlights Verzenio data for HR+ and HER2- breast cancer at ASCO Annual Meeting 2023.

Presentations include new analyses from the Phase III monarchE trial of two years of Verzenio treatment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC) and updated data from the Phase 1/II BRUIN trial for an approved use of Jaypirca in patients with covalent BTK inhibitor pre-treated relapsed or refractory mantle cell lymphoma (MCL).

"These additional data on Verzenio and Jaypirca build on the evidence supporting the role each of these medicines play in improving the treatment paradigms for patients with node-positive, high risk early breast cancer and covalent BTK inhibitor pre-treated relapsed or refractory MCL, respectively," said David Hyman, M.D., chief medical officer, Loxo@Lilly. "Mature data for Verzenio reinforce its benefit in the node-positive, high risk adjuvant setting across age groups and these data should also provide comfort that the durable efficacy observed is not compromised when dose reductions are necessary. We also continue to be encouraged by these longer-term follow up data for Jaypirca and the potential for treatment to extend the time patients with relapsed or refractory MCL may benefit from BTK inhibition therapy."

New Analyses from the Verzenio monarchE Trial: An oral presentation (Abstract #501) will highlight efficacy and safety results from age-based subgroup analyses from the Phase III monarchE study of Verzenio in combination with endocrine therapy (ET) in patients with HR+, HER2-, node-positive EBC at a high risk of recurrence. Previously reported four-year data from monarchE demonstrated that, with all patients off Verzenio, Verzenio with ET compared to ET alone reduced the risk of recurrence by 34% and the risk of distant relapse by 34% in this node positive, high risk EBC population, with a persistent and growing benefit demonstrated beyond the two-year treatment period with Verzenio – supporting the goal of eradicating micrometastatic disease to prevent recurrence even after patients have completed treatment.

The new analyses show similar efficacy across age groups and in patients who had dose adjustments . Adjuvant Verzenio plus ET demonstrated an absolute benefit in invasive disease-free survival (IDFS) rate of 5.9% in those age 65 and older (n=850) and 6.4% in patients under 65 (n=4,787). Rates of adverse events (AEs) were also similar between age groups; 54% of patients 65 and older experienced Grade 3 and above AEs compared with 49% of patients under 65. Dose adjustments due to AEs were more common in patients age 65 and older. The impact of dose adjustments was evaluated among all patients enrolled in monarchE, regardless of age. In this analysis, patients were classified into three equal-sized subgroups according to their relative dose intensity (RDI) of Verzenio. IDFS outcomes at four years were similar across RDI subgroups (RDI from lowest dose intensity group to highest: 87.1%, 86.4%, 83.7%), showing treatment benefit is maintained despite dose modifications.

Patient-reported quality of life (QoL) data collected at baseline, 3, 6, 12, 18, and 24 months during the treatment period will also be presented, across all patients in monarchE. These results demonstrated overall QoL scores were similar for patients taking Verzenio plus ET and patients taking ET alone and were maintained in all age subgroups during the two-year Verzenio treatment period.

"The long-term efficacy and safety results from these analyses of the monarchE trial further demonstrate the benefit of adding two years of Verzenio to ET in the adjuvant setting, showing similar efficacy regardless of age, and even for those who have undergone dose modifications," said Erika P. Hamilton, M.D., medical oncologist, director of Breast Cancer Research at Sarah Cannon Research Institute and an investigator on the monarchE clinical trial. "These data, combined with new patient-reported outcomes, support the role of two years of Verzenio as the standard of care for people with HR+, HER2- early breast cancer and will be important for informing Verzenio treatment management."