Eli Lilly to unveil phase III EMBER-3 trial results for Imlunestrant at San Antonio Breast Cancer Symposium

Eli Lilly and Company announced that data from the Phase III trial (EMBER-3) for imlunestrant, an oral selective estrogen receptor degrader (SERD), will be reported for the first time in a late-breaking oral presentation at the San Antonio Breast cancer Symposium (SABCS) ) taking place December 10-13 in San Antonio, TX. EMBER-3 is a study in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer. The trial is evaluating imlunestrant alone or in combination with Verzenio (abemaciclib; CDK4/6 inhibitor), in patients who were pretreated with endocrine therapy, with or without a CDK4/6 inhibitor.

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

A full list of abstract titles and viewing details are listed below:

Imlunestrant (investigational oral SERD)
Presentation Title: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy and Combined with Abemaciclib, for Patients with ER+, HER2- Advanced Breast Cancer (ABC), Pretreated with Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial.
Presentation Number: GS1-01
Presentation Date & Time: Wednesday, Dec.11, 2024, 9:15-9:30 a.m. CST
Location: Hall 1
Presenter: Komal Jhaveri

Presentation Title: Patient and health care provider perspectives on oral versus intramuscular endocrine therapy for locally advanced or metastatic breast cancer
Presentation Number: P4-03-11
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Rebecca Speck

Presentation Title: Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairment
Presentation Number: P4-10-07
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Xuejing Aimee Wong

Real World Evidence
Presentation 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
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Sara Tolaney

Verzenio® (abemaciclib)
Presentation Title: 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
Presentation Number: P1-01-26
Presentation Date &Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Seth Wander

Presentation Title: 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
Presentation Number: P1-11-29
Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Hatem Soliman

Presentation Title: Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin Analysis
Presentation Number: P5-02-23
Presentation Date & Time: Friday, Dec.13, 2024, 12-2 p.m. CST
Location: Halls 2-3
Presenter: Mamoru Takada

PI3Ka Inhibitor (LOXO-783)
Presentation Title: A first-in-human phase 1a/b trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant, allosteric PI3Kα H1047R inhibitor advanced breast cancer and other solid tumors: Results from the PIKASSO-01 study
Presentation Number: PS7-03
Presentation Date & Time: Wednesday, Dec.11, 2024, 7-8:30 a.m. CST
Location: TBD
Presenter: Komal Jhaveri

Next-Gen PI3Ka Inhibitor (LY4045004)
Presentation Title: Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitor
Presentation Number: P4-12-24
Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST
Location: Halls 2-3
Presenter: Raymond Gilmour (Lilly)