Featured Company News – Eli Lilly Announces That Verzenio Failed To Meet Primary Endpoint of Overall Survival in Phase-3 JUNIPER Study
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LONDON, UK / ACCESSWIRE / October 12, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Eli Lilly and Co. (NYSE: LLY) ("Eli Lilly"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=LLY. The Company announced on October 10, 2017, that its Phase-3 JUNIPER study assessing the safety and efficacy of Verzenio (abemaciclib) as a monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). Nonetheless, an analysis of the secondary study endpoints, that is progression-free survival (PFS) and overall response rate (ORR), exhibited evidence of monotherapy activity in the abemaciclib arm. Besides, the control arm also demonstrated higher than expected survival rate, based on historical data in this setting. Eli Lilly declared that it would submit the data for presentation at a medical meeting in 2018. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Verzenio (abemaciclib) is an inhibitor of CDK4 and CDK6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 encourage phosphorylation of the retinoblastoma protein, cell cycle progression, and cell proliferation.
Verzenio disrupts the cell cycle. Preclinically, when Verzenio is dosed daily without interruption as a single agent or in combination with antiestrogens, it leads to a decrease in the size of the tumor.
However, in vitro, it has been observed that continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, which led to senescence and apoptosis, meaning cell death.
It is believed that inhibiting CDK4 & 6 in healthy cells can result in serious side effects.
Besides, as per clinical evidence, Verzenio crosses the blood-brain barrier.
About JUNIPER
JUNIPER is a global Phase-3, interventional, open-label study which has been designed to assess the efficacy and safety of Verzenio versus erlotinib (a drug made by Roche) in patients with stage IV NSCLC with a detectable KRAS mutation, who have improved after platinum-based chemotherapy and who may have received one additional systemic therapy.
Study design - This study randomized 453 patients to take 200 mg of Verzenio orally twice a day on a continuous dosing schedule every 12 hours, or 150 mg of erlotinib administered at its approved dose and schedule until disease progression, death, or unacceptable toxicity.
Primary and secondary endpoints - The primary endpoint of the study was overall survival, while key secondary endpoints include safety, overall response rate, and progression-free survival.
Adverse Events - The JUNIPER study demonstrated that the adverse events were mostly in-line with the previous studies of abemaciclib. Diarrhea, fatigue, decreased appetite, and nausea are some of the common adverse events that were reported.
Eli Lilly Oncology to Remain Focused on Discovering Potential Treatment for NSCLC
Levi Garraway, M.D., Ph.D., Senior Vice President, Global Development and Medical Affairs, at Eli Lilly Oncology, shared his views about the JUNIPER results. He stated that the outcome is particularly unfortunate for patients with KRAS-mutated advanced lung cancer. But he mentioned that Eli Lily Oncology is still motivated with the antitumor activity observed with Verzenio in this form of lung cancer, where very few clinical advances have been achieved as of now. Eli Lilly has been working towards delivering life-changing medicines for those suffering from cancer for over 50 years now.
Dr. Garraway also mentioned that his team is analyzing secondary endpoints and exploring specific patient subgroups to better evaluate the prospects of Verzenio for treating NSCLC. Moreover, Eli Lilly will continue to work with the oncology community to explore potential future treatment avenues for patients with KRAS-mutated advanced lung cancer. In fact, numerous studies are already under progress for evaluating rational combinations that include Verzenio in non-small cell lung cancer and other malignancies. The results of these studies are eagerly awaited.
Negative Impact on Stock
After the Company made the announcement about the trial results, shares of Eli Lilly fell around 4.2% on premarket trade on October 10, 2017. This year, Eli Lilly has suffered setbacks on two potential treatments: (i) the delay of a rheumatoid arthritis drug in April, and (ii) the failure of an experimental Alzheimer's treatment in November.
Last Close Stock Review
On Wednesday, October 11, 2017, the stock closed the trading session at $86.06, marginally down 0.12% from its previous closing price of $86.16. A total volume of 3.21 million shares have exchanged hands. Eli Lilly's stock price advanced 4.73% in the past one month, 2.43% in the last three months and 5.19% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 17.01%. The stock is trading at a PE ratio of 37.30 and has a dividend yield of 2.42%. At Wednesday's closing price, the stock's net capitalization stands at $94.01 billion.
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