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Lilly Announces Details of Presentations at ESMO Congress 2023

Published: 2023-10-06 11:45:00 ET

INDIANAPOLIS, Oct. 6, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), Retevmo® (selpercatinib; a rearranged during transfection [RET] inhibitor), and imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]) will be presented at the 2023 European Society for Medical Oncology (ESMO) Congress taking place October 20-24 in Madrid.

Presentation HighlightsVerzenio (abemaciclib)In a late-breaking oral presentation, Lilly will share five-year results, an established benchmark for adjuvant breast cancer trials, from a preplanned interim analysis of the Phase 3 monarchE study. The trial is evaluating two years of adjuvant Verzenio treatment in combination with endocrine therapy (ET) compared with ET alone in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive early breast cancer (EBC) at a high risk of recurrence. A separate poster presentation will provide data on the impact of dose reductions on efficacy for patients treated in monarchE.

Retevmo (selpercatinib)In two late-breaking oral presentations that will be featured as part of the Presidential Symposium 1 on Saturday, October 21, Lilly will share interim analysis results from the Phase 3 LIBRETTO-431 and LIBRETTO-531 clinical studies. LIBRETTO-431 evaluated Retevmo versus platinum-based chemotherapy – with or without pembrolizumab – as an initial treatment for patients with RET fusion-positive non-small cell lung cancer (NSCLC). LIBRETTO-531 evaluated Retevmo versus multikinase inhibitors (cabozantinib or vandetanib) in patients with advanced RET-mutant medullary thyroid cancer (MTC).

Imlunestrant (investigational oral SERD)In a mini oral presentation, Lilly will share clinical data on imlunestrant as a single agent and in combination therapy. These results include the first clinical data for imlunestrant in combination with everolimus or alpelisib and updated imlunestrant monotherapy data from the Phase 1 EMBER study in patients with estrogen receptor positive (ER+), HER2- advanced breast cancer.

Abstract titles and viewing details are listed below:

Verzenio (abemaciclib):Presentation Title: Adjuvant abemaciclib plus endocrine therapy for high-risk, HR+, HER2-, early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomesFPN #:LBA17Presentation Date & Time:Friday, October 20, 14:00 – 14:10 CESTSession: Breast cancer, early stageLocation:Bilbao Auditorium - NCCPresenter: Nadia Harbeck

Presentation Title: Impact of Dose Reductions on Efficacy of Adjuvant Abemaciclib for Patients with High-Risk Early Breast Cancer (EBC): Analyses from the monarchE StudyFPN #:274PPresentation Date & Time: Saturday, October 21, 12:00 – 13:00 CESTSession: Breast cancer, early stageLocation: Hall 8Presenter: Joyce O'Shaughnessy

Presentation Title: Prognostic and predictive impact of estrogen/progesterone receptor (ER/PR), and Ki-67 expression: an exploratory analysis from the monarchE trial in patients with high-risk, HR+, HER2- early breast cancer (EBC)FPN #: 240MOPresentation Date & Time:Monday, October 23, 17:00 – 17:05 CESTSession: Breast cancer, early stageLocation:Bilbao Auditorium - NCCPresenter: Matthew P. Goetz

Presentation Title: Evolution and Risk Stratification of Adjuvant Treatment Strategies for Early Breast Cancer: A Chinese Perspective Based on National Cancer DatabaseFPN #:256PPresentation Date & Time:Saturday, October 21, 12:00 – 13:00 CESTSession: Breast cancer, early stageLocation: Hall 8Presenter: Ying Fan

Retevmo (selpercatinib):Presentation Title: Randomized Phase 3 Study of First-line Selpercatinib versus Pembrolizumab and Chemotherapy in RET Fusion-positive NSCLC (DV-011345)Presentation Date & Time:Saturday, October 21, 17:35 – 17:47 CESTFPN #:LBA4Session:Presidential 1 (ID 65) (Saturday, October 21, 16:30-18:15 CEST)Location:Madrid Auditorium – Hall 6Presenter: Herbert Ho Fung Loong

Presentation Title: Randomized Phase 3 Study of Selpercatinib versus Cabozantinib or Vandetanib in Advanced, Kinase Inhibitor-Naïve, RET-mutant Medullary Thyroid Cancer (DV-014219)FPN #:LBA3Presentation Date & Time:Saturday, October 21, 17:10 – 17:22 CESTSession:Presidential 1 (ID 65) (Saturday, October 21, 16:30-18:15 CEST)Location:Madrid Auditorium – Hall 6Presenter: Julien Hadoux

Presentation Title: Patient-Reported Outcomes with Selpercatinib in Patients with RET-driven cancers in the Phase 1/2 LIBRETTO-001 Trial (DV-013416)FPN #:669PPresentation Date & Time:Monday, October 23, 12:00 – 13:00 CESTSession: Developmental therapeuticsLocation: Hall 8Presenter: Hyunseok Kang

Presentation Title: Updated safety and efficacy of selpercatinib in patients (pts) with RET-activated thyroid cancer: Data from LIBRETTO-001 (DV-011352)FPN #:2229PPresentation Date & Time:Sunday, October 22, 12:00 – 13:00 CESTSession: Thyroid cancerLocation: Hall 8Presenter: Lori J. Wirth

Imlunestrant (investigational oral SERD):Presentation Title: Imlunestrant with or without everolimus or alpelisib, in ER+, HER2- advanced breast cancer (aBC): Results from the Phase 1a/b EMBER studyFPN #:383MOPresentation Date & Time:Sunday, October 22, 9:05 – 9:10 CESTSession: Breast cancer, metastaticLocation: Bilbao Auditorium - NCCPresenter: Komal Jhaveri

Presentation Title: A preoperative window-of-opportunity (WOO) study of imlunestrant in ER+, HER2- early breast cancer (EBC): Results from EMBER-2FPN #:273PPresentation Date & Time:Saturday, October 21, 12:00 – 13:00 CESTSession: Breast cancer, early stageLocation: Hall 8Presenter: Patrick Neven

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 and only CDK4/6 inhibitor approved to treat node-positive, high risk early breast cancer (EBC) patients.1 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.2 NCCN® also includes Verzenio plus endocrine therapy as a preferred treatment option for metastatic breast cancer.2

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, the only adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a high risk population.3 In metastatic breast cancer, Verzenio has demonstrated statistically significant OS in the Phase 3 MONARCH 2 study.4 Verzenio has shown a consistent and generally manageable safety profile across clinical trials. In addition to breast cancer, Lilly is studying Verzenio in different forms of difficult-to-treat prostate cancer.

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 the first diarrhea event 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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