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Lilly's Imlunestrant Phase 3 EMBER-3 Data to be Presented at SABCS 2024

10 months ago3 min read

Key Insights

  • Eli Lilly's Imlunestrant, an oral selective estrogen receptor degrader (SERD), will have its Phase 3 EMBER-3 trial results presented at the San Antonio Breast Cancer Symposium (SABCS).

  • The EMBER-3 trial evaluated Imlunestrant alone or combined with Verzenio (abemaciclib) in pretreated ER+, HER2- advanced breast cancer patients.

  • Lilly will also share real-world data on recurrence risk in HR+, HER2- early breast cancer and preclinical data for next-gen PI3Ka inhibitor LY4045004.

Eli Lilly and Company will present data from the Phase 3 EMBER-3 trial of imlunestrant, an oral selective estrogen receptor degrader (SERD), at the San Antonio Breast Cancer Symposium (SABCS) in December. The EMBER-3 trial focuses on estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.
The study investigates imlunestrant as a monotherapy and in combination with Verzenio (abemaciclib), a CDK4/6 inhibitor, in patients previously treated with endocrine therapy, with or without a CDK4/6 inhibitor. The presentation (GS1-01) by Komal Jhaveri is scheduled for December 11, 2024, at 9:15-9:30 a.m. CST in Hall 1.

Additional Breast Cancer Data Presentations

In addition to the EMBER-3 data, Lilly will present a real-world analysis of recurrence risk based on nodal status and high-risk features in patients with hormone receptor-positive (HR+), HER2- early breast cancer. Sara Tolaney will present this analysis (P1-11-02) on December 11, 2024, from 12-2 p.m. CST in Halls 2-3.
Further presentations will cover investigational mutant selective PI3Ka inhibitor assets, including preclinical characterization data for LY4045004, expected to enter clinical trials in the first half of 2025. Phase 1a/b clinical data for LOXO-783, a predecessor molecule that informed the development of LY4045004, will also be shared. Raymond Gilmour (Lilly) will present the LY4045004 data (P4-12-24) on December 12, 2024, from 5:30-7 p.m. CST in Halls 2-3, while Komal Jhaveri will present LOXO-783 data (PS7-03) on December 11, 2024, from 7-8:30 a.m. CST.

Verzenio (abemaciclib) Presentations

Lilly will also present several abstracts related to Verzenio (abemaciclib), a CDK4/6 inhibitor approved for HR+, HER2- breast cancers. These include:
  • Genomic profiling of ctDNA and association with efficacy in patients from the postMONARCH trial of abemaciclib + fulvestrant vs placebo + fulvestrant for HR+, HER2-, advanced breast cancer following progression on a prior CDK4/6i plus endocrine therapy (P1-01-26).
  • Clinical Characteristics and Treatment Persistence in US Patients with HR+/HER2-, Node Positive Early Breast Cancer Treated with Abemaciclib: Real-World Study from First Year After Approval (P1-11-29).
  • Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin Analysis (P5-02-23).

About Imlunestrant

Imlunestrant is an oral selective estrogen receptor (ER) degrader designed to provide continuous ER inhibition, including in ESR1-mutant cancers. It is currently under investigation for advanced breast cancer and as an adjuvant treatment in early breast cancer.

About Verzenio (abemaciclib)

Verzenio is a CDK4/6 inhibitor approved for 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. It functions by blocking CDK4 and CDK6, preventing cell cycle progression and tumor growth.
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