Lilly to Present Phase 3 Imlunestrant Results at San Antonio Breast Cancer Symposium

INDIANAPOLIS, Nov. 1, 2024 -- Eli Lilly and Company (NYSE: LLY) has revealed that data from the Phase 3 EMBER-3 trial for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be presented for the first time at the San Antonio Breast Cancer Symposium (SABCS) on December 10-13 in San Antonio, TX. This trial focuses on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. It examines imlunestrant alone or combined with Verzenio (abemaciclib; CDK4/6 inhibitor) in patients pretreated with endocrine therapy, with or without a CDK4/6 inhibitor.

Lilly will also present findings from a real-world analysis of recurrence risk by nodal status and high-risk features in patients with hormone receptor positive (HR+), HER2- early breast cancer. Additional presentations will include preclinical characterization data for LY4045004, an investigational mutant selective PI3Ka inhibitor expected to enter clinical trials in the first half of 2025, and Phase 1a/b clinical data for LOXO-783, which informed the development of LY4045004.

The presentation schedule at SABCS includes several significant sessions. Presentations on imlunestrant will cover its efficacy as a monotherapy and in combination with abemaciclib for ER+, HER2- advanced breast cancer pretreated with endocrine therapy. Another presentation will discuss the perspectives of patients and health care providers on oral versus intramuscular endocrine therapy for advanced or metastatic breast cancer. The pharmacokinetics and safety of imlunestrant in participants with hepatic impairment will also be evaluated.

Real-world evidence presentations will explore the risk of recurrence by nodal status and high-risk features in HR+, HER2- early breast cancer based on real-world data. Verzenio® (abemaciclib) will also be highlighted in multiple sessions, including genomic profiling of circulating tumor DNA (ctDNA) and its association with efficacy in patients from the postMONARCH trial. Other presentations will focus on treatment persistence in US patients with HR+/HER2- node-positive early breast cancer treated with abemaciclib, and the antitumor mechanism of abemaciclib in human breast cancer.

Additionally, findings from a first-in-human Phase 1a/b trial of LOXO-783, a potent and highly mutant-selective PI3Kα H1047R inhibitor for advanced breast cancer and other solid tumors, will be presented. Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitor, will also be discussed.

Verzenio® (abemaciclib) has been approved for treating certain HR+, HER2- breast cancers in both adjuvant and advanced/metastatic settings. It is the first CDK4/6 inhibitor approved for node-positive, high-risk early breast cancer patients. The National Comprehensive Cancer Network® (NCCN®) recommends considering two years of abemaciclib with endocrine therapy for adjuvant treatment and also lists it as a preferred option for metastatic breast cancer. Clinical trials have shown Verzenio provides substantial benefits, including statistically significant overall survival in the Phase 3 MONARCH 2 study and continued efficacy beyond the two-year treatment period in high-risk early breast cancer.

Verzenio is administered orally twice daily, available in various strengths, and has been approved in over 90 countries since its initial approval in 2017. It has demonstrated a consistent safety profile across clinical trials, despite some severe side effects like diarrhea, neutropenia, and interstitial lung disease. Monitoring and managing these potential adverse effects are crucial for patient safety.

Imlunestrant, another promising candidate, is an oral selective estrogen receptor degrader targeting estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. It aims to overcome endocrine therapy resistance and provide consistent oral pharmacology. Currently, it is under investigation for its efficacy in both advanced and early breast cancer treatment.

Eli Lilly and Company continues to advance its clinical development programs, striving to provide effective treatments for breast cancer and other diseases.