Blog Coverage Eli Lilly’s Late-Stage Bladder Cancer Drug CYRAMZA Meets Primary Endpoint

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LONDON, UK / ACCESSWIRE / June 2, 2017 / Active Wall St. blog coverage looks at the headline from Global Pharma MNC Eli Lilly And Co. (NYSE: LLY) as the Company announced on May 31, 2017, that its Phase-3 Range study of Late-Stage Bladder Cancer Drug CYRAMZA® (ramucirumab) met its primary endpoint which was improving the progression – free survival (PFS). The improved PFS denotes an improvement that has great significance, statistically. 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, Alimera Sciences, Inc. (NASDAQ: ALIM), announced on May 08, 2017, its top-line financial results for Q1 2017 which ended on March 31, 2017. AWS will be initiating a research report on Alimera Sciences in the coming days.

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Commenting on CYRAMZA® (ramucirumab) meeting its endpoint, Levi Garraway, M.D., Ph.D., Senior Vice President, Global Development and Medical Affairs of Lilly Oncology said:

“While there have been several recent advancements to treat this type of cancer, most patients progress despite treatment with existing therapies, including immune checkpoint inhibitors. Until now, no Phase-3 study has demonstrated superior PFS over chemotherapy in this setting. These results are encouraging and we look forward to seeing the overall survival results when they are mature.”

About the RANGE Phase 3 trails

Eli Lilly conducted Phase-3 trials for CYRAMZA that was global, randomized, double-blinded, and placebo-controlled to evaluate the impact of ramucirumab in combination with docetaxel in patients with locally advanced or unresectable (a tumor that cannot be removed completely through surgery) or metastatic urothelial carcinoma (urinary cancer that can occur in the bladder, ureters, and renal pelvis) whose disease progressed on or after platinum-based chemotherapy.

The RANGE Study included 531 patients from across the globe. The study included:

1) patients who progressed following adjuvant and/or neoadjuvant therapy;

2) patients who progressed following first-line metastatic therapy;

and 3) patients who had received prior platinum-based and immune checkpoint inhibitor regimens.

The primary endpoint of the study was progression-free survival and secondary endpoints included overall survival, objective response rate, disease control rate, and duration of response.

The RANGE study of the Phase-3 trial was started after successful completion of Phase-2 study with the same criteria of treatment for patients treated with a combination of ramucirumab and docetaxel. The Phase-2 results showed a statistically significant improvement in PFS and disease control rate, and a numerically higher objective response rate.

RANGE is the first Phase-3 trial investigating ramucirumab in urothelial cancer patients. The results of the RANGE study reveal that it is the first therapy of its kind that shows superior PFS results compared to chemotherapy in a post-platinum setting while treating urothelial cancer. Ramucirumab becomes the first antiangiogenic agent to extend PFS in a Phase-3 trial in urothelial cancer. Antiangiogenics are drugs that stop cancers from growing blood vessels. This slows the growth of cancer or sometimes shrinks it.

RANGE study included patients that were previously treated with a checkpoint inhibitor. The safety profile observed in the RANGE study at this analysis was consistent with what has been previously observed for ramucirumab.

Eli Lilly plans to share the detailed findings of the RANGE study at a future medical meeting. The Company has reiterated that although the primary endpoint has been met, the overall survival results will call for global regulatory submissions. The overall survival results are expected in mid-2018.

About CYRAMZA® (ramucirumab)

Eli Lilly’s CYRAMZA® (ramucirumab) is approved to be used as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Ramucirumab is being investigated in a broad global development program that has enrolled more than 10,000 patients across more than 70 trials worldwide. There are several studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.

About Urothelial Cancer

Urothelial carcinoma, also known as transitional cell carcinoma (TCC), is one of the most common types of bladder cancer. These cancers start in the urothelial cells that line the inside of the bladder. Urothelial cells also line other parts of the urinary tract, such as the part of the kidney that connects to the ureter (called the renal pelvis), the ureters, and the urethra.

According to World Cancer Research Fund International, Bladder cancer is the ninth most common cancer in the world, with 430,000 new cases diagnosed in 2012. Men are most likely to get bladder cancer compared to women. Smoking is one of the major causes for bladder cancer. The highest incidence of bladder cancer is in Northern America and Europe.

Stock Performance

Eli Lilly’s share price finished yesterday’s trading session at $79.99, rising slightly by 0.53%. A total volume of 3.09 million shares exchanged hands. The stock has surged 19.12% and 6.74% in the last six months and past twelve months, respectively. Furthermore, since the start of the year, shares of the Company have gained 8.76%. The stock is trading at a PE ratio of 38.85 and has a dividend yield of 2.60%. The stock currently has a market cap of $88.58 billion.

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