Verzenio (abemaciclib)
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Lilly to highlight progress across key programs in early and advanced hormone receptor-positive breast cancer at the 2025 San Antonio Breast Cancer Symposium
Prnewswire· 2025-11-24 21:30
Accessibility StatementSkip Navigation Updated results from the Phase 3 EMBER-3 trial for Inluriyoâ"¢ (imlunestrant) alone and in combination with Verzenio (abemaciclib) in ER+, HER2– metastatic breast cancer to be presented as a late-breaking oral presentation Updated safety and efficacy data to be presented from PIKALO-1, the Phase 1/2 trial of Lilly's pan-mutant- selective PI3K inhibitor, which will be advanced into the Phase 3 PIKALO-2 study New subgroup analysis from the Phase 3 monarchE trial that exp ...
Lilly's EBGLYSS (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis
Prnewswire· 2025-10-24 10:45
Core Insights - Eli Lilly's EBGLYSS (lebrikizumab-lbkz) shows promising results in treating moderate-to-severe atopic dermatitis, with approximately 80% of patients achieving or maintaining meaningful skin improvement with less frequent dosing [1][5] - The company has submitted new data to the FDA for a potential label update, which could allow for a maintenance dosing schedule of once every eight weeks [1][3] Group 1: Clinical Data and Efficacy - In the Phase 3 ADjoin extension trial, patients receiving EBGLYSS every eight weeks achieved similar disease control rates as those receiving it every four weeks, with 79% and 86% achieving EASI 75, respectively [5][9] - The study also reported that 62% of patients on the eight-week regimen and 73% on the four-week regimen achieved IGA 0 or 1, indicating significant skin clearance [5][9] - There were no new safety findings or increased risk of immunogenicity associated with the less frequent dosing [5][9] Group 2: Treatment Flexibility and Patient Experience - The new dosing schedule could reduce the treatment burden for patients, allowing for as few as six maintenance doses per year, which may enhance patient adherence and quality of life [2][3] - The interleukin-13 (IL-13) inhibitor mechanism of EBGLYSS targets a key cytokine involved in atopic dermatitis, potentially offering a more effective treatment option for patients [2][20] Group 3: Regulatory and Market Position - Lilly is pursuing an FDA label update for the every-eight-week dosing option, while also exploring a twelve-week dosing regimen in ongoing studies [4][3] - EBGLYSS is positioned as a first-line biologic treatment for moderate-to-severe atopic dermatitis, with strong recommendations from the American Academy of Dermatology [4][8] Group 4: Commercial Strategy and Access - Lilly has secured coverage for EBGLYSS with all three major national pharmacy benefit managers, ensuring access for over 90% of individuals with commercial insurance [25] - The company is also working to expand Medicaid and Medicare coverage as part of its health access initiative [25]
Lilly confirms date and conference call for third-quarter 2025 financial results announcement
Prnewswire· 2025-10-16 14:00
Core Insights - Eli Lilly and Company will announce its third-quarter 2025 financial results on October 30, 2025, followed by a conference call for investors and media [1] - The company emphasizes its commitment to advancing healthcare through innovative treatments and clinical trials that reflect global diversity [1] Financial Results Announcement - The financial results will be disclosed on October 30, 2025, with a conference call starting at 10 a.m. Eastern time [1] - A live webcast of the conference call will be available on Lilly's website, with a replay accessible afterward [1] Company Overview - Eli Lilly has been a pioneer in medical discoveries for nearly 150 years, focusing on improving lives through biotechnology, chemistry, and genetic medicine [1] - The company addresses significant health challenges, including diabetes care, obesity treatment, Alzheimer's disease, immune system disorders, and difficult-to-treat cancers [1] - Lilly aims to ensure that its medicines are accessible and affordable while conducting innovative clinical trials [1]
Lilly to present new clinical data for Verzenio (abemaciclib) and multiple novel pipeline programs at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting
Prnewswire· 2025-10-13 10:45
Core Insights - Eli Lilly and Company is presenting new data from its oncology portfolio at the ESMO Annual Meeting, highlighting advancements in cancer care and the efficacy of its investigational therapies [1][7]. Group 1: Verzenio (abemaciclib) - The company will present results from the seven-year analysis of the Phase 3 monarchE study, focusing on overall survival and disease-free survival in high-risk early breast cancer patients [2][10]. - An in-depth analysis of the Ki-67 index's prognostic and predictive value will also be shared, examining its role before and after neoadjuvant chemotherapy [2]. Group 2: Investigational Therapies - Olomorasib, a KRAS G12C inhibitor, will have its intracranial efficacy results presented for patients with KRAS G12C-mutant non-small cell lung cancer [3]. - LY4064809, a pan-mutant-selective PI3Ka inhibitor, will showcase updated results from the Phase 1/2 PIKALO-1 trial in PIK3CA-mutant advanced breast cancer [4]. - Vepugratinib, an FGFR3 inhibitor, will present updated results from the FORAGER-1 study in FGFR3-altered urothelial cancer [5]. - LY4170156, an investigational antibody-drug conjugate targeting folate receptor alpha, will share updated safety and efficacy results in patients with platinum-resistant ovarian cancer [6]. Group 3: Company Commitment - The presentations reflect Lilly's commitment to advancing cancer care and improving patient outcomes, with a focus on strengthening its oncology portfolio [7].
Lilly announces details of presentations at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Prnewswire· 2025-05-22 21:05
Core Insights - Eli Lilly and Company is set to present data on several investigational drugs at the 2025 ASCO Annual Meeting, including imlunestrant, olomorasib, LY4170156, and Verzenio [1] Group 1: Imlunestrant (Investigational Oral SERD) - The company will present patient-reported outcomes from the Phase 3 EMBER-3 trial for patients with ER+, HER2- advanced breast cancer [2] - Expanded safety analyses from the EMBER-3 trial will also be featured in a poster presentation [2] Group 2: Olomorasib (Investigational KRAS G12C Inhibitor) - Updated results from a Phase 1/2 study of olomorasib will be reported, showing preliminary evidence of CNS activity in combination with pembrolizumab for KRAS G12C-mutant advanced NSCLC and with cetuximab for KRAS G12C-mutant colorectal cancer [3] - The presentations will utilize data cut-off dates of January 15, 2025, and November 13, 2024 [3] Group 3: LY4170156 (Investigational ADC Targeting FRα) - Initial results from a Phase 1a/1b study of LY4170156 in patients with platinum-resistant ovarian cancer will be presented [4] - The study involves a humanized monoclonal antibody linked to a topoisomerase I inhibitor [4] Group 4: Verzenio (Abemaciclib) - The impact of body mass index (BMI) on the efficacy and safety of Verzenio in breast cancer patients will be discussed [8] - Verzenio is an approved treatment for certain HR+, HER2- breast cancers and is available in multiple strengths [12][13]