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Lilly presents patient-reported outcomes from the positive phase III monarchE trial for Verzenio at St. Gallen Virtual Congress 2021.

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Published:18th Mar 2021
Eli Lilly and Company announced patient-reported outcomes (PRO) for the investigational use of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC) The PRO analysis included patients in both arms of the study and measured their experiences with side effects, symptoms, and health-related quality of life, in those receiving Verzenio plus ET versus ET alone. In one analysis, the PRO data indicated that most patients (approximately 70-75%) in both arms reported being bothered "a little bit" or "not at all" by treatment-related side effects. This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects. The detailed data were presented at the virtual 17th St. Gallen International Breast Cancer Conference. The data builds on the primary outcome analysis of the positive Phase III monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). PROs were assessed at randomization, during treatment (3 months onwards) and in the follow-up period (safety population, n=5591). Overall, patient compliance for PROs was greater than 90 percent. Expectedly, patient-reported diarrhea was more common in patients receiving Verzenio plus ET. Most patients who experienced diarrhea while receiving Verzenio plus ET reported having diarrhea "a little bit" or "somewhat." Health-related quality of life, patient-reported endocrine symptoms and fatigue, as well as patient responses to items reflecting hot flushes, arthralgia and fatigue were similar between treatment arms. With the exception of diarrhea, the addition of Verzenio to ET did not result in any clinically meaningful differences in the PROs. The PRO poster was selected for one of the three St. Gallen International Breast Cancer Conference Poster Awards 2021. The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints. The abstracts presented at St. Gallen will be published in a supplement issue of The Breast, available on March 17, 2021. About the monarchE Study : monarchE is a Phase III, multicenter, randomized, open-label trial that enrolled 5,637 patients with HR+, HER2-, node-positive, high risk early breast cancer. Patients were randomized 1:1 to Verzenio (150 mg twice daily) plus standard adjuvant endocrine therapy or standard adjuvant endocrine therapy alone. Patients were treated for two years (treatment period) or until meeting criteria for discontinuation. After the treatment period, all patients will continue on endocrine therapy for five to 10 years, as clinically indicated. The primary objective is invasive disease-free survival (IDFS) defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. High risk was specifically defined as women (any menopausal status) and men with resected HR+, HER2- invasive early breast cancer with either greater than 4 pathologically positive axillary lymph nodes (ALNs) or 1 to 3 positive ALNs and at least one of the following high-risk features: primary invasive tumor size ?5 cm, histological grade 3 tumor, or central Ki-67 index greater than 20%. If applicable, patients must have also completed adjuvant chemotherapy and radiotherapy prior to enrolling and have recovered from all acute side effects.
Condition: Breast Cancer HER2+
Type: drug

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