Eli Lilly to present new data from cancer research pipeline at ESMO

Data from 20 studies across Eli Lilly's oncology product portfolio will be presented at the European Society for Medical Oncology, or ESMO, virtual congress, September 19-21. The data include results from the Phase 3 monarchE study of Verzenio in combination with standard adjuvant endocrine therapy, or ET, for the treatment of high risk HR+, HER2- early breast cancer. Lilly continues to investigate Verzenio across the breast cancer continuum, which has now shown results in people with high risk HR+, HER2- early breast cancer. At ESMO, Lilly will share detailed results from the Phase 3 monarchE study, which demonstrated Verzenio plus standard adjuvant ET significantly decreased the risk of breast cancer recurrence compared to standard adjuvant ET alone in people with high risk HR+, HER2- early breast cancer. These results make Verzenio the only CDK4 & 6 inhibitor to demonstrate statistically significant improvement in invasive disease-free survival in this setting. Lilly also will present findings on genomic testing, biomarkers and treatment patterns in early breast cancer as well as the use of Ki-67 testing and scoring in HR+, HER2- early breast cancer - a biomarker of particular interest in the study of high risk early breast cancer. Additional Verzenio data to be presented include a final overall survival analysis of Verzenio monotherapy in patients with HR+, HER2- advanced breast cancer in the nextMONARCH trial. The approval of Retevmo - a selective RET kinase inhibitor - marked the most rapid timeline in the development of an oncology medicine with multiple indications, and was based on results from the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET-altered cancers. During ESMO, Lilly will present patient-reported outcomes and quality of life findings from both the RET fusion-positive NSCLC and RET-mutant MTC patient cohorts. Lilly will also present new safety data on patients with previously treated metastatic RET fusion-positive NSCLC, including safety and efficacy outcomes assessed by category of last systemic therapy received prior to LIBRETTO-001 enrollment. An additional safety analysis, focusing on hypersensitivity reactions in RET fusion-positive NSCLC patients previously treated with immune checkpoint inhibitors, will also be presented. Details on the study design of two confirmatory Phase 3 trials, LIBRETTO-431 and LIBRETTO-531, will additionally be shared. Both Phase 3 trials are currently enrolling patients. Earlier this year, the FDA approved CYRAMZA in combination with erlotinib for the first-line treatment of people with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, based on results from the Phase 3 RELAY study. With this approval, CYRAMZA has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers. CYRAMZA was also approved in the European Union earlier this year based on the RELAY results. During ESMO, Lilly will feature data from the RELAY trial looking at outcomes by EGFR mutation type in previously untreated EGFR-mutated metastatic NSCLC patients. Additionally, a systematic literature review will spotlight outcomes of treated patients with EGFR-mutated NSCLC harboring exon 19 deletions or exon 21 mutations.