Lilly to Present Phase 3 EMBER-3 Study Results for Imlunestrant at San Antonio Breast Cancer Symposium

Eli Lilly and Company (NYSE: LLY) has announced that data from the Phase 3 EMBER-3 trial of imlunestrant, an oral selective estrogen receptor degrader (SERD), will be presented for the first time in a late-breaking oral session at the San Antonio Breast Cancer Symposium (SABCS), scheduled for December 10-13 in San Antonio, TX. The EMBER-3 study focuses on patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. It evaluates the effectiveness of imlunestrant alone or in combination with Verzenio (abemaciclib; a CDK4/6 inhibitor) in patients previously treated with endocrine therapy, with or without a CDK4/6 inhibitor.

Lilly will also share findings from a real-world analysis assessing the risk of recurrence based on nodal status and high-risk features in patients with hormone receptor positive (HR+), HER2- early breast cancer. Additionally, the company will present preclinical data on its investigational mutant-selective PI3Kα inhibitor, LY4045004, which is set to enter clinical trials in the first half of 2025, along with Phase 1a/b clinical data for its predecessor molecule, LOXO-783, which informed the development of LY4045004.

Presentation Details:

Imlunestrant (Investigational Oral SERD)

  • Title: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib for Patients with ER+, HER2- Advanced Breast Cancer: Results of the Phase 3 EMBER-3 Trial.
  • Presentation Number: GS1-01
  • Date & Time: Wednesday, Dec. 11, 2024, 9:15-9:30 a.m. CST
  • Location: Hall 1
  • Presenter: Komal Jhaveri
  • Title: Patient and Healthcare Provider Perspectives on Oral vs. Intramuscular Endocrine Therapy for Locally Advanced or Metastatic Breast Cancer
  • Presentation Number: P4-03-11
  • Date & Time: Thursday, Dec. 12, 2024, 5:30-7 p.m. CST
  • Location: Halls 2-3
  • Presenter: Rebecca Speck
  • Title: Evaluation of Pharmacokinetics and Safety of Imlunestrant in Participants with Hepatic Impairment
  • Presentation Number: P4-10-07
  • Date & Time: Thursday, Dec. 12, 2024, 5:30-7 p.m. CST
  • Location: Halls 2-3
  • Presenter: Xuejing Aimee Wong

Real-World Evidence

  • Title: Risk of Recurrence by Nodal Status and High-Risk Features in Patients with HR+, HER2-, Early Breast Cancer: An Analysis of Real-World Data
  • Presentation Number: P1-11-02
  • Date & Time: Wednesday, Dec. 11, 2024, 12-2 p.m. CST
  • Location: Halls 2-3
  • Presenter: Sara Tolaney

Verzenio® (Abemaciclib)

  • Title: Genomic Profiling of ctDNA and Its Association with Efficacy in Patients from the postMONARCH Trial of Abemaciclib + Fulvestrant vs. Placebo + Fulvestrant for HR+, HER2-, Advanced Breast Cancer Following Progression on Prior CDK4/6i Plus Endocrine Therapy
  • Presentation Number: P1-01-26
  • Date & Time: Wednesday, Dec. 11, 2024, 12-2 p.m. CST
  • Location: Halls 2-3
  • Presenter: Seth Wander
  • Title: Clinical Characteristics and Treatment Persistence in U.S. Patients with HR+/HER2-, Node Positive Early Breast Cancer Treated with Abemaciclib: Real-World Study from First Year After Approval
  • Presentation Number: P1-11-29
  • Date & Time: Wednesday, Dec. 11, 2024, 12-2 p.m. CST
  • Location: Halls 2-3
  • Presenter: Hatem Soliman
  • Title: Unveiling the Antitumor Mechanism of Abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin Analysis
  • Presentation Number: P5-02-23
  • Date & Time: Friday, Dec. 13, 2024, 12-2 p.m. CST
  • Location: Halls 2-3
  • Presenter: Mamoru Takada

PI3Kα Inhibitor (LOXO-783)

  • Title: A First-in-Human Phase 1a/b Trial of LOXO-783, a Potent, Highly Mutant-Selective, Brain-Penetrant, Allosteric PI3Kα H1047R Inhibitor for Advanced Breast Cancer and Other Solid Tumors: Results from the PIKASSO-01 Study
  • Presentation Number: PS7-03
  • Date & Time: Wednesday, Dec. 11, 2024, 7-8:30 a.m. CST
  • Location: TBD
  • Presenter: Komal Jhaveri

Next-Gen PI3Kα Inhibitor (LY4045004)

  • Title: Preclinical Characterization of LY4045004, a Next-Generation, Mutant-Selective PI3Kα Inhibitor
  • Presentation Number: P4-12-24
  • Date & Time: Thursday, Dec. 12, 2024, 5:30-7 p.m. CST
  • Location: Halls 2-3
  • Presenter: Raymond Gilmour (Lilly)

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