Blog Coverage Eli Lilly's Breast Cancer Drug Achieved its Primary Endpoint in Late Stage Trial
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LONDON, UK / ACCESSWIRE / April 25, 2017 / Active Wall St. blog coverage looks at the headline from Eli Lilly and Co. (NYSE: LLY) as the Company announced that its MONARCH 3 trial met its primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS). Additionally, the late stage clinical trial showed improvement in a key secondary endpoint of objective response rate (ORR). Register with us now for your free membership and blog access at:
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One of Eli Lilly's competitors within the Drug Manufacturers - Major space, Shire PLC (NASDAQ: SHPG), is expected to report its fiscal quarter ending March 2017 earnings on May 02, 2017 before market open. AWS will be initiating a research report on Shire PLC in the coming days.
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The MONARCH Study
The global Phase-3, double-blind, placebo-controlled study named MONARCH 3 was designed to evaluate the efficacy and safety of abemaciclib, in combination with an aromatase inhibitor (letrozole or anastrozole) as initial endocrine-based therapy, for postmenopausal women with advanced hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have had no prior systemic treatment for advanced disease. For the study a total of 493 patients were randomized to receive 150 mg of abemaciclib or placebo orally twice a day without interruption, given in combination with either 1 mg of anastrozole or 2.5 mg of letrozole once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was PFS, with key secondary endpoints of ORR, overall survival and safety. The adverse events were generally consistent with previous studies of abemaciclib, with the most common adverse events being diarrhea, neutropenia, fatigue, and nausea.
"Today marks another important milestone in our clinical development program for abemaciclib, a drug we believe has the potential to be best in class," said Levi Garraway, M.D., Ph.D., Senior Vice President of global development and medical affairs, Lilly Oncology, "We are very excited about the results seen in patients with breast cancer, from single-agent activity to clinically meaningful benefit when used in combination with fulvestrant or aromatase inhibitors."
Following this MONARCH 3 interim analysis, Eli Lilly intends to begin global submissions of these results in Q3 2017. Additionally, Eli Lilly intends to initiate MONARCH 1 and MONARCH 2 submissions beginning in Q2 2017.
Abemaciclib
Eli Lilly's Abemaciclib is an investigational, oral cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting cyclin-dependent kinases, CDK4 and CDK6 and was most active against Cyclin D1 and CDK4 in cell-free enzymatic assays. In breast cancer, Cyclin D1/CDK4 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. In addition to its current MONARCH clinical trials evaluating abemaciclib in breast cancer, Eli Lilly's abemaciclib is also being tested in other clinical trials, including in lung cancer, brain metastases and pancreatic 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. Eli Lilly estimated 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 of all early stage breast cancer cases diagnosed in the US, approximately 30% will become metastatic, spreading to other parts of the body. In addition, an estimated 6% to 10% pf all new breast cancer cases are initially diagnosed as being stage IV, or metastatic. Metastatic breast cancer is considered incurable, but is generally treatable.
Stock Performance
On Monday, April 24, 2017, following the announcement, the stock closed the trading session at $83.42, climbing 1.87% from its previous closing price of $81.89. A total volume of 4.80 million shares have exchanged hands, which was higher than the 3-month average volume of 3.85 million shares. Eli Lilly's stock price advanced 10.04% in the last three months, 7.36% in the past six months, and 10.03% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 14.18%. The stock is trading at a PE ratio of 32.36 and has a dividend yield of 2.49%.
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