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Lilly Announces Details of Presentations at ESMO Congress 2022

Published: 2022-09-07 22:05:00 ET
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INDIANAPOLIS, Sept. 7, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that data from studies of Verzenio® (abemaciclib) and Retevmo® (selpercatinib) will be presented at the 2022 European Society for Medical Oncology (ESMO) Congress, to be held September 9-13, 2022.

Presentation HighlightsVerzenio (abemaciclib)Lilly will present interim overall survival results from the double-blind, randomized Phase 3 MONARCH 3 study of Verzenio in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer as well as final overall survival results from the Phase 2 monarcHER study in HR+, HER2+ advanced breast cancer.

Retevmo (selpercatinib)Lilly will present longer-term follow-up data for patients with medullary thyroid cancer (MTC) and data on the continuation of Retevmo beyond progression in patients with rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) from the Retevmo LIBRETTO-001 trial.

A list of the presentations, along with their viewing details, is shared below.

Medicine

Abstract Title

Details

Verzenio

(abemaciclib)

MONARCH 3: Interim overall survival(OS) results of abemaciclib plus anonsteroidal aromatase inhibitor (NSAI)in patients (pts) with HR+, HER2-advanced breast cancer (ABC)

Abstract #LBA15

Proffered Paper Session: Breast Cancer, Metastatic

Friday, September 9

16:00 – 16:10 CEST

Verzenio

(abemaciclib)

Final overall survival (OS) forabemaciclib plus trastuzumab +/-fulvestrant versus trastuzumab pluschemotherapy in patients with HR+,HER2+ advanced breast cancer(monarcHER): a randomized, open-label, phase 2 trial

Abstract #LBA18

Mini Oral Session: Breast Cancer, Metastatic

Saturday, September 10

14:45 – 14:50 CEST

Retevmo

(selpercatinib)

Durable efficacy of selpercatinib inpatients (pts) with medullary thyroidcancer (MTC): Update of theLIBRETTO-001 trial

Abstract #1656P

Poster Session

Sunday, September 11

12:00 – 13:00 CEST

Retevmo (selpercatinib)

Continuation of selpercatinib beyondprogression in RET fusion-positiveNSCLC: Data from LIBRETTO-001study

Abstract #980P

Poster Session

Monday, September 12

12:00 – 13:00 CEST

About Verzenio® (abemaciclib)Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a nonchemotherapy oral tablet.

Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells so that 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 VERZENIO®Verzenio® (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 a U.S. Food and Drug Administration (FDA)-approved test.

Verzenio is also indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:

  • In combination with ET (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA-approved test
  • In combination with an aromatase inhibitor as initial ET for the treatment of postmenopausal women, and men, with HR+, HER2- advanced or metastatic breast cancer
  • In combination with fulvestrant for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following ET
  • As monotherapy for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer with disease progression following ET and prior chemotherapy in the metastatic setting

About Retevmo® (selpercatinib)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 a U.S. Food and Drug Administration (FDA)-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (