INDIANAPOLIS, May 26, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from its oncology portfolio will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 3-7, 2022. The data include new analyses from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), Retevmo® (selpercatinib; a selective RET inhibitor), and imlunestrant (an investigational, oral selective estrogen receptor degrader [SERD]).
Presentation HighlightsVerzenio (abemaciclib)Lilly will present analyses from the Verzenio Phase 3 monarchE study in high-risk HR+, HER2- early breast cancer assessing factors associated with increasing risk of treatment discontinuation.
Retevmo (selpercatinib)Lilly will present an update on the tumor agnostic efficacy of Retevmo in patients with RET fusion-positive solid tumors other than lung and thyroid cancer treated on the global, multicenter registrational LIBRETTO-001 trial.
ImlunestrantLilly will present updated monotherapy results from the ongoing, first-in-human, Phase 1 EMBER trial of imlunestrant in patients with estrogen receptor positive advanced breast cancer and endometrioid endometrial cancer. The submitted abstract utilized a January 2022 data cut-off date, and the poster discussion will utilize a March 2022 data cut-off date.
A list of the poster presentations, along with their viewing details, are shared below.
Medicine | Abstract Title and Lead Author | Details |
Verzenio (abemaciclib) | Adjuvant abemaciclib for high risk early breast cancer: Factors associated with increasing risk of treatment discontinuations in monarchE; S. Tolaney. | Abstract 527 Session: Breast Cancer – Local/Regional/Adjuvant Poster Monday, June 6, 8–11 a.m. CDT |
Retevmo (selpercatinib)
| Tumor Agnostic Efficacy of Selpercatinib in Patients with RET Fusion+ Solid Tumors: A Global, Multicenter, Registrational Trial Update (LIBRETTO-001); V. Subbiah.
| Abstract 3094 Session: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology Poster Sunday, June 5, 8–11 a.m. CDT |
Imlunestrant
| A Phase 1a/b trial of imlunestrant (LY3484356), an oral selective estrogen receptor degrader in ER-positive advanced breast cancer and endometrial endometrioid cancer: Monotherapy results from EMBER; KL Jhaveri. | Abstract 1021 Session: Breast Cancer – Metastatic Poster Discussion Monday, June 6, 8–11 a.m. CDT; 11:30 a.m. – 1 p.m. CDT. |
Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet.
Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 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.
INDICATIONS FOR VERZENIOVerzenio® (abemaciclib) in combination with endocrine therapy (ET) is indicated for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test.
Verzenio is also indicated for the treatment of HR+ HER2- advanced or metastatic breast cancer:
Retevmo® (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a selective and potent rearranged during transfection (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 (