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INDIANAPOLIS, May 19, 2021 /PRNewswire/ -- New data from across Eli Lilly and Company's (NYSE: LLY) oncology portfolio will be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 4-8, 2021. The data include new analyses of Verzenio® (abemaciclib) from the Phase 3 monarchE trial in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC) with a high risk of recurrence who received neoadjuvant chemotherapy. In addition, the first clinical data from the Phase 1 study of Lilly's oral selective estrogen receptor degrader (SERD) will be presented at the meeting.
Breast Cancer HighlightsVerzenio® (abemaciclib) Lilly will present a subgroup analysis from the positive Phase 3 monarchE trial in high-risk early breast cancer detailing the invasive disease-free survival, distant relapse-free survival, and safety outcomes in patients who received neoadjuvant chemotherapy, as well as an analysis of a subgroup of patients from China. In addition, Lilly is publishing new pre-clinical data which examine unique attributes of Verzenio among CDK4 & 6 inhibitors. Lilly will also present an analysis of real world evidence on the risk of recurrence in early breast cancer.
Oral SERDLoxo Oncology at Lilly will present an analysis of interim clinical data from the ongoing, first-in-human, Phase 1a trial of LY3484356 in patients with estrogen receptor positive advanced breast cancer and endometrial endometrioid cancer. The submitted abstract utilized a November 2020 data cut-off date, and the poster presentation will utilize an April 2021 data cut-off date.
Lung and Thyroid Cancer HighlightsRetevmo® (selpercatinib)Lilly will present new data on Retevmo, including preliminary results from the Phase 1/2 LIBRETTO-121 trial in pediatric patients with advanced RET-altered solid tumors, as well as further efficacy and safety updates from the Phase 1/2 LIBRETTO-001 study of Retevmo in patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic RET-altered thyroid cancer.
In addition, analyses of racial disparities in biomarker testing – including next-generation sequencing – and clinical trial enrollment among patients with NSCLC will be presented at the meeting.
Gastrointestinal Cancer HighlightsCYRAMZA® (ramucirumab) and ERBITUX® (cetuximab)Lilly will present data on prognostic and predictive factors in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein treated with CYRAMZA, along with real world evidence on ERBITUX in patients with metastatic colorectal cancer.
A list of the oral and poster presentations, along with their viewing details, as well as published abstracts are shared below.
Breast Cancer | ||
Medicine | Abstract Title and Lead Author | Presentation Details |
Verzenio(abemaciclib) | Abemaciclib combined with adjuvantendocrine therapy in patients with high risk early breast cancer who received neoadjuvant chemotherapy; Miguel Martin | Abstract 517 Session: Breast Cancer—Local/Regional/Adjuvant Poster Discussion Friday, June 4, at 9:00-10:00 a.m. EDT |
Verzenio(abemaciclib) | Efficacy and safety analysis of Chinese patients in monarchE: abemaciclib combined with adjuvant endocrine therapy for high risk HR+,HER2- early breast cancer; Shao Zhimin | Abstract 522 Session: Breast Cancer—Local/Regional/Adjuvant Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Verzenio(abemaciclib) | Characterizing demographics, clinical, and genomic characteristics for USpatients with HR+, HER2- metastaticbreast cancer following progression on a CDK4 and 6 inhibitor; Fabrice Andre | Abstract 1015 Session: Breast Cancer—Metastatic Poster Discussion Friday, June 4, at 9:00-10:00 a.m. EDT |
Verzenio(abemaciclib) | eMonarcHER: A phase 3 study of abemaciclib plus standard adjuvant endocrine therapy in patients with HR+, HER2+, node-positive, high risk early breast cancer; Sara M. Tolaney | Abstract TPS596 Session: Breast Cancer—Local/Regional/Adjuvant Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Verzenio(abemaciclib) | A phase Ib study of xentuzumab plus abemaciclib and fulvestrant in patients (pts) with advanced hormone receptor-positive (HR+),HER2-negative breast cancer (BC) with visceral or non-visceral disease; Douglas Yee | Abstract 1057 Session: Breast Cancer—Metastatic Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Verzenio(abemaciclib) | Recurrence risk in early breast cancer as defined by clinicopathologic features; Kristin M. Sheffield | Abstract e18581 Publication only: Health Services Research and Quality Improvement |
Verzenio(abemaciclib) | Abemaciclib, a CDK4 & 6 inhibitor with unique pharmacological properties for breast cancer therapy; Torres Raquel | Abstract e12506 Publication only: Breast Cancer—Local/Regional/Adjuvant |
LY3484356(oral SERD) | A first-in-human phase 1a/b trial of LY3484356, an oral selective estrogen receptor (ER) degrader (SERD) in ER+ advanced breast cancer (aBC) and endometrial endometrioid cancer (EEC):Results from the EMBER study; Komal Jhaveri | Abstract 1050 Session: Breast Cancer—Metastatic Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Lung and Thyroid Cancers | ||
Medicine | Abstract Title and Lead Author | Presentation Details |
Retevmo(selpercatinib) | Oral Selpercatinib in Pediatric Patients (pts) with Advanced RET-Altered Solid or Primary CNS Tumors: Preliminary Results from the Phase 1/2 LIBRETTO-121Trial; Daniel Morgenstern | Abstract 10009 Session: Pediatric Oncology II Oral presentation Friday, June 4, at 9:00 a.m. EDT |
Retevmo(selpercatinib) | Updated Overall Efficacy and Safety of Selpercatinib in Patients(pts) with RET Fusion+ Non-Small-Cell Lung Cancer (NSCLC); Benjamin Besse | Abstract 9065 Session: Lung Cancer—Non-Small Cell Metastatic Poster Available on demand startingFriday, June 4 at 9:00 a.m. EDT |
Retevmo(selpercatinib) | Selpercatinib efficacy and safety in patients with RET-altered thyroid cancer: a clinical trial update; Eric Sherman | Abstract 6073 Session: Head and Neck Cancer Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Retevmo(selpercatinib) | Efficacy of Selpercatinib After PriorSystemic Therapy in Patients withRET Mutant Medullary Thyroid Cancer; Lori J. Wirth | Abstract 6074 Session: Head and Neck Cancer Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Retevmo(selpercatinib) | Response to Selpercatinib Versus Prior Systemic Therapy in Patients (Pts) with RET Fusion+ Non-Small-Cell Lung Cancer (NSCLC); Alexander E. Drillon
| Abstract 9032 Session: Lung Cancer—Non-Small Cell Metastatic Available on demand startingFriday, June 4 at 9:00 a.m. EDT |
N/A | Racial Disparities in Biomarker Testing and Clinical Trial Enrollment in Non-Small Cell Lung Cancer (NSCLC); Debora S. Bruno | Abstract 9005 Session: Lung Cancer—Non-Small Cell Metastatic Oral presentation Friday, June 4, at 1:00 p.m. EDT |
N/A | Challenges in Lung Cancer Multidisciplinary Collaboration Experienced by Specialists in Four Countries; Monaliben Patel MD | Abstract e23002 Publication only: Professional Development and Education Advances |
Gastrointestinal Cancers | ||
Medicine | Abstract Title and Lead Author | Presentation Details |
CYRAMZA (ramucirumab) | Prognostic and predictive factors in patients treated with ramucirumab (RAM) with advanced hepatocellular carcinoma (aHCC) and elevated alpha-fetoprotein (AFP): results from two Phase III trials; Joseph M. Llovet | Abstract 4146 Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
ERBITUX(cetuximab) | Real-World Time on Treatment and Overall Survival in Patients with Metastatic Colorectal cancer receiving Cetuximab in Second Line after failing Irinotecan or Oxaliplatin-based Regimens; Wambul Gathirua-Mwangi | Abstract e15568 Publication only: Gastrointestinal Cancer – Colorectal and Anal
|
ERBITUX(cetuximab) | A Retrospective Analysis of Real-World Time on Treatment and Overall Survivalin Patients with Metastatic Colorectal Cancer receiving Cetuximab in Third Line; Wambui Gathirua-Mwangi | Abstract e15575 Publication only: Gastrointestinal Cancer – Colorectal and Anal |
Prostate Cancer | ||
Medicine | Abstract Title and Lead Author | Presentation Details |
Verzenio(abemaciclib) | CYCLONE 1: A Phase 2 study of abemaciclib in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a novel hormonal agent and taxane-based chemotherapy; Neeraj Agarwal | Abstract TPS5086 Session: Genitourinary Cancer—Prostate, Testicular, and Penile Poster Available on demand starting Friday, June 4 at 9:00 a.m. EDT |
Other | ||
Medicine | Abstract Title and Lead Author | Presentation Details |
olaratumab | Phase (Ph) 1b/2 evaluation ofolaratumab in combination with gemcitabine and docetaxel in advanced soft tissue sarcoma (STS); Steven Attia | Abstract 11517 Session: Sarcoma Poster Discussion Friday, June 4, at 9:00 a.m. – 11:00 a.m. EDT |
N/A | Racial distribution of clinical trial participants in the United States; Monaliben Patel | Abstract e18516 Publication only: Health Services Research and Quality Improvement |
Notes to Editors
About Verzenio® (abemaciclib)Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.
In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.
Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
INDICATION FOR VERZENIOVerzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:
About LY3484356LY3484356 is an investigational, oral selective estrogen receptor degrader (SERD) with pure antagonistic properties. The estrogen receptor (ER) is the key therapeutic target for patients with ER+/HER2- breast cancer. Novel degraders of ER may overcome endocrine therapy resistance while providing consistent oral pharmacology and convenience of administration. LY3484356 was specifically designed to deliver continuous estrogen receptor target inhibition throughout the dosing period and regardless of ESR1 mutational status.
LY3484356 is currently being studied in the first-in-human, multi-center Phase 1a/1b EMBER trial in patients with estrogen receptor positive locally advanced or metastatic breast cancer and other select non-breast cancers and in the Phase 1 EMBER-2 trial in preoperative, postmenopausal women with stage I-III, ER+/HER2- breast cancer. For additional information about LY3484356 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology at Lilly clinical trial team by e-mailing clinicaltrials@loxooncology.com.
About Retevmo® (selpercatinib)Retevmo (selpercatinib, capsules 40mg, 80mg; formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a selective and potent RET kinase inhibitor. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is an U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (
