INDIANAPOLIS, Nov. 21, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that study investigators will present data from its breast cancer portfolio and pipeline at the 2022 San Antonio Breast Cancer Symposium (SABCS), to be held December 6-10, 2022, in San Antonio, Texas, and virtually. These presentations include new results from studies of Verzenio® (abemaciclib; a CDK4/6 inhibitor), imlunestrant (an investigational oral selective estrogen receptor degrader [SERD]), and LOXO-783 (an investigational mutant-selective allosteric PI3Kα H1047R inhibitor).

The Verzenio oral and poster presentations will provide updated clinical data from ongoing studies in early and advanced forms of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. An oral presentation will provide results from a pre-planned overall survival (OS) analysis from the Phase 3 monarchE study in HR+, HER2-, node-positive, high risk early breast cancer, including four-year efficacy outcomes. Updated results at the final OS from the Phase 3 MONARCH 2 trial of Verzenio plus fulvestrant in patients with HR+, HER2- advanced breast cancer will be presented in a spotlight poster discussion. Additional analyses include real-world evidence in early breast cancer with a high risk of recurrence.

In a spotlight poster discussion, combination therapy results with imlunestrant will be presented from the Phase 1 EMBER trial of imlunestrant in combination with Verzenio, with or without an aromatase inhibitor, in patients with estrogen receptor positive (ER+), HER2- advanced breast cancer. In addition, pharmacodynamic data from the preoperative EMBER-2 trial evaluating imlunestrant in ER+, HER2- early breast cancer will be provided. Preclinical data with LOXO-783 in combination with standard-of-care breast cancer agents will also be presented at the meeting.

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

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 ImlunestrantImlunestrant (LY3484356) 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. Imlunestrant was specifically designed to deliver continuous estrogen receptor target inhibition throughout the dosing period and regardless of ESR1 mutational status. Imlunestrant is currently being studied in several clinical studies.

For information about imlunestrant clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo@Lilly clinical trial team by e-mailing clinicaltrials@loxooncology.com.

About LOXO-783LOXO-783 is an investigational potent, highly mutant-selective and brain-penetrant allosteric PI3Kα H1047R inhibitor that is designed to spare wild-type PI3Kα, other PI3K isoforms, and other kinases. Phosphoinositide 3-kinase alpha (PI3Kα) H1047R mutations are activating oncogenic events that occur in approximately 15 percent of breast cancers and less commonly in other cancers. LOXO-783 has shown preclinical activity without on-target wild-type PI3Kα mediated toxicity. LOXO-783 is being investigated in an open-label, multicenter, Phase 1a/1b study in patients with PIK3CA H1047R-mutant advanced breast cancer and other solid tumors.

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