Blog Coverage Eli Lilly Announced Positive Results from Breast Cancer Drug Combination Study

Upcoming AWS Coverage on AbbVie

LONDON, UK / ACCESSWIRE / March 22, 2017 / Active Wall St. blog coverage looks at the headline from US drugmaker Eli Lilly and Co. (NYSE: LLY) as the Company announced on March 20, 2017, that its MONARCH 2 trial of its breast cancer drug, abemaciclib, whose Phase-3 trial in lung cancer is also under way, met the primary endpoint of progression-free survival (PFS). Register with us now for your free membership and blog access at:

http://www.activewallst.com/register/

One of Eli Lilly’s competitors within the Drug Manufacturers – Major space, AbbVie Inc. (NYSE: ABBV), is estimated to report earnings on April 27, 2017. AWS will be initiating a research report on AbbVie following the release of its next earnings results.

Today, AWS is promoting its blog coverage on LLY; touching on ABBV. Get all of our free blog coverage and more by clicking on the link below:

http://www.activewallst.com/register/

The Phase-III Study

Eli Lilly’s global Phase-3, double-blind study was designed to evaluate the efficacy and safety of abemaciclib, in combination with fulvestrant, in patients with advanced (locoregionally recurrent or metastatic) breast cancer. A total of 669 patients were randomized to receive abemaciclib or placebo orally twice a day on a continuous dosing schedule, given in combination with fulvestrant. Patients enrolled in the study had experienced disease progression on or within 12 months of receiving endocrine treatment in the neoadjuvant or adjuvant setting or while receiving first-line endocrine therapy for metastatic disease.

Eli Lilly’s Phase-3 study evaluated abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with fulvestrant in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy. The results demonstrated the addition of abemaciclib to fulvestrant resulted in a statistically significant improvement in PFS.

“We are excited about the outcome of our first Phase-3 study for abemaciclib. These data are an important milestone in our goal of bringing abemaciclib to patients with advanced breast cancer, and we look forward to our upcoming conversations with regulators,” said Levi Garraway, M.D., Ph.D., Senior Vice President, global development and medical affairs, Lilly Oncology.

Way Forward

Eli Lilly announced that it plans to submit a new drug application (NDA) for single-agent abemaciclib in Q2 2017, based on the MONARCH 1 study, while the Company plans to submit an additional application for MONARCH 2 in Q3 2017.

Along with MONARCH 1 and MONARCH 2, the Company is carrying out additional trials evaluating abemaciclib in breast cancer. MONARCH 3 is a Phase-3 trial of abemaciclib in combination with a nonsteroidal aromatase inhibitor in patients with HR+, HER2- advanced breast cancer. Furthermore, there is a Phase-2 MONARCH trial under way: monarcHER, which is evaluating abemaciclib plus trastuzumab in women with HR+, HER2+ locally advanced or metastatic breast cancer.

About Metastatic Breast Cancer

Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012 as reported. In the official press release, the Company noted that in the US this year, approximately 252,710 new cases of invasive breast cancer will be diagnosed and about 40,610 people will die from breast cancer. The Company noted that out of all early stage breast cancer cases diagnosed in the US, approximately 30% will become metastatic, spreading to other parts of the body.

What is Abemaciclib?

Abemaciclib 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 and was most active against Cyclin D1 and CDK 4 in cell-free enzymatic assays. In breast cancer, Cyclin D1/CDK 4 has been shown to promote phosphorylation of the retinoblastoma protein (Rb), cell proliferation, and tumor growth. In hormone receptor–positive breast cancer cell lines, sustained target inhibition by abemaciclib reduced phosphorylation of Rb, inducing cell cycle arrest.

In 2015, the US 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.

Stock Performance

On Tuesday, March 21, 2017, Eli Lilly’s share price finished the trading session at $83.73, slightly down 0.39%. A total volume of 4.07 million shares exchanged hands. The stock has surged 14.98% and 22.36 % in the last three months and past twelve months, respectively. Furthermore, since the start of the year, shares of the Company have gained 14.61%. The stock is trading at a PE ratio of 32.48 and has a dividend yield of 2.48%.

Active Wall Street:

Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

AWS has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:

The non-sponsored content contained herein has been prepared by a writer (the “Author”) and is fact checked and reviewed by a third party research service company (the “Reviewer”) represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the “Sponsor”), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.

NO WARRANTY

AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/.

CONTACT

For any questions, inquiries, or comments reach out to us directly. If you’re a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:

Email: info@activewallst.com

Phone number: 1-858-257-3144

Office Address: 3rd floor, 207 Regent Street, London, W1B 3HH, United Kingdom

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE: Active Wall Street

ReleaseID: 457900