Lilly Presents neoMONARCH Phase 2 Data on Abemaciclib in Early-Stage Breast Cancer

Abemaciclib - alone or in combination with anastrozole - significantly reduced Ki67 in neoadjuvant HR+/HER2- breast cancer

SAN ANTONIODec. 8, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the neoMONARCH study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, met its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation, after two weeks of treatment. Final data from the Phase 2 trial presented during the official press program at the 2016 San Antonio Breast Cancer Symposium (SABCS) evaluated abemaciclib, both alone or in combination with the non-steroidal aromatase-inhibitor anastrozole, in postmenopausal women with previously untreated early stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

"Lilly is committed to the scientific discovery and development of new therapies that change current standards of cancer care," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. "The neoMONARCH data are encouraging and continue to inform our understanding of how abemaciclib could be used as both a single-agent therapy or in combination with aromatase inhibitors, such as anastrozole, in the early-stage setting."

The Phase 2 neoMONARCH trial was a randomized, multi-center, open-label study that enrolled 224 patients who had at least one measurable tumor ≥1 cm, adequate organ function, and an ECOG performance status of ≤1. Patients were randomized to one of three trial arms: 1) twice-daily abemaciclib monotherapy (150mg) for two weeks; 2) twice-daily abemaciclib (150mg) along with once-daily anastrozole (1mg) for two weeks; or 3) once-daily anastrozole monotherapy (1mg) for two weeks. All patients received an initial biopsy prior to randomization to assess baseline Ki67 expression. After the initial two-week treatment period, patients underwent a second tumor biopsy and Ki67 was assessed again.

The primary objective of the study was to assess Ki67 percentage change in the breast tumor after two weeks of therapy from the baseline measurement. The results showed that abemaciclib monotherapy and abemaciclib in combination with anastrozole significantly reduced Ki67 more than anastrozole alone. Following the initial two weeks of randomized treatment, all patients then went on to receive twice-daily abemaciclib (150mg) plus anastrozole (1mg) for a further 14 to 22 weeks.

The study protocol also included the prophylactic use of loperamide (2mg) administered twice-daily, in combination with abemaciclib for the first 28 days. No new safety signals were observed for abemaciclib when administered in combination with anastrozole.

Breast cancer is the most common cancer among American women, besides skin cancers, and is the second leading cause of cancer death among women.1 An estimated 61,000 cases of early-stage breast cancer will be diagnosed in the U.S. this year and one in eight women, or 12 percent, of women in the U.S. will develop invasive breast cancer during their lifetime.1

About Abemaciclib 
Abemaciclib (LY2835219) is an investigational, oral cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting cyclin-dependent kinases, CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of cell cycle regulation due to increased signaling from CDK 4 and CDK 6. Abemaciclib inhibits both CDK 4 and CDK 6, and was shown in cell-free enzymatic assays to be most active against Cyclin D 1 and CDK 4.

In 2015, the U.S. Food and Drug Administration granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company's Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. In addition to its current MONARCH clinical trials evaluating abemaciclib in breast cancer, a Phase 3 trial of abemaciclib in lung cancer is also underway.

For more information on additional abemaciclib trials, a complete listing can be found on ClinicalTrials.gov (in the search box on the home page, type in "abemaciclib").

About Lilly Oncology 
For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high- quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channelsP-LLY    

© Lilly USA, LLC 2016. ALL RIGHTS RESERVED.

Lilly Forward-Looking Statement 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about abemaciclib as a potential treatment for patients with breast cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that abemaciclib will achieve its primary study endpoints or receive regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward- looking statements to reflect events after the date of this release.

1 The American Cancer Society. 2016 American Cancer Society Breast Cancer Factsheet. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics. Accessed: December 7, 2016.

Refer to:  
Erin Gravesgraves_erin_elissa@lilly.com; 908-202-6354 (media)  
Phil Johnsonjohnson_philip_l@lilly.com; 317-655-6874 (investors)  

 


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