Lilly to Present Results from Phase 3 EMBER-3 Study of Imlunestrant, an Oral SERD, and Additional Results from Its Breast Cancer Portfolio at the San Antonio Breast Cancer Symposium
INDIANAPOLIS, Nov. 1, 2024 /PRNewswire/ --Â Eli Lilly and Company (NYSE: LLY) today announced that data from the Phase 3 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:Â 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:Â GS1-01Presentation Date & Time: Wednesday, Dec.11, 2024, 9:15-9:30 a.m. CSTLocation: Hall 1Presenter:Â Komal Jhaveri
Presentation Title: Patient and health care provider perspectives on oral versus intramuscular endocrine therapy for locally advanced or metastatic breast cancerPresentation Number:Â P4-03-11Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CSTLocation: Halls 2-3Presenter:Â Rebecca Speck
Presentation Title:Â Evaluation of pharmacokinetics and safety of imlunestrant in participants with hepatic impairmentPresentation Number:Â P4-10-07Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CSTLocation: Halls 2-3Presenter:Â Xuejing Aimee Wong
Real World EvidencePresentation Title:Â Risk of Recurrence by Nodal Status and High-Risk Features in Patients with HR+, HER2-, Early Breast Cancer: An Analysis of Real-world DataPresentation Number:Â P1-11-02Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter:Â 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 therapyPresentation Number: P1-01-26Presentation Date &Time: Wednesday, Dec.11, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter: Seth Wander
Presentation Title:Â 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 ApprovalPresentation Number:Â P1-11-29Presentation Date & Time: Wednesday, Dec.11, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter:Â Hatem Soliman
Presentation Title:Â Unveiling the Antitumor Mechanism of abemaciclib in Human Breast Cancer Through Circulating Tumor Chromatin AnalysisPresentation Number:Â P5-02-23Presentation Date & Time:Â Friday, Dec.13, 2024, 12-2 p.m. CSTLocation: Halls 2-3Presenter:Â 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 studyPresentation Number: PS7-03Presentation Date & Time: Wednesday, Dec.11, 2024, 7-8:30 a.m. CSTLocation: TBDPresenter: Komal Jhaveri
Next-Gen PI3Ka Inhibitor (LY4045004) Presentation Title: Preclinical characterization of LY4045004, a next-generation, mutant-selective PI3Kα inhibitorPresentation Number: P4-12-24Presentation Date & Time: Thursday, Dec.12, 2024, 5:30-7 p.m. CST Location: Halls 2-3Presenter: Raymond Gilmour (Lilly)
About Verzenio® (abemaciclib) Verzenio® (abemaciclib) is approved to treat people with certain HR+, HER2- breast cancers in the adjuvant and advanced or metastatic setting. Verzenio is the first CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients. The National Comprehensive Cancer Network® (NCCN®) recommends consideration of two years of abemaciclib (Verzenio) added to endocrine therapy as a Category 1 treatment option in the adjuvant setting.1 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.1Â
The collective results of Lilly's clinical development program continue to differentiate Verzenio as a CDK4/6 inhibitor. In high risk EBC, Verzenio has shown a persistent and deepening benefit beyond the two-year treatment period in the monarchE trial, an adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high-risk population.2 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.3 Verzenio has shown a consistent and generally manageable safety profile across clinical trials.
Verzenio is an oral tablet taken twice daily and available in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. Discovered and developed by Lilly researchers, Verzenio was first approved in 2017 and is currently authorized for use in more than 90 counties around the world. For full details on indicated uses of Verzenio in HR+, HER2- breast cancer, please see full Prescribing Information, available at www.Verzenio.com.
INDICATIONS FOR VERZENIO®VERZENIO® is a kinase inhibitor indicated:
- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
- in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
- as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)Severe diarrhea associated with dehydration and infection occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, diarrhea occurred in 81 to 90% of patients who received Verzenio. Grade 3 diarrhea occurred in 8 to 20% of patients receiving Verzenio. Most patients experienced diarrhea during the first month of Verzenio treatment. The median time to onset of diarrhea ranged from 6 to 8 days; and the median duration of Grade 2 and Grade 3 diarrhea ranged from 6 to 11 days and 5 to 8 days, respectively. Across trials, 19 to 26% of patients with diarrhea required a Verzenio dose interruption and 13 to 23% required a dose reduction.
Instruct patients to start antidiarrheal therapy, such as loperamide, at the first sign of loose stools, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to ≤Grade 1, and then resume Verzenio at the next lower dose.
Neutropenia, including febrile neutropenia and fatal neutropenic sepsis, occurred in patients treated with Verzenio. Across four clinical trials in 3691 patients, neutropenia occurred in 37 to 46% of patients receiving Verzenio. A Grade ≥3 decrease in neutrophil count (based on laboratory findings) occurred in 19 to 32% of patients receiving Verzenio. Across trials, the median time to first episode of Grade ≥3 neutropenia ranged from 29 to 33 days, and the median duration of Grade ≥3 neutropenia ranged from 11 to 16 days. Febrile neutropenia has been reported in
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