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Lilly Announces Second Positive Ramucirumab Phase III Gastric Cancer Study Meets Primary Endpoint; Phase III Lilly/TRIO Breast Cancer Study Misses Primary Endpoint
Date:9/26/2013

INDIANAPOLIS, Sept. 26, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced top-line results from two global Phase III studies of ramucirumab (IMC-1121B), one in advanced gastric cancer and another in metastatic breast cancer.

The RAINBOW trial, a global Phase III study of ramucirumab in combination with paclitaxel in patients with advanced gastric cancer, met its primary endpoint of improved overall survival and a secondary endpoint of improved progression-free survival.

The global, randomized, double-blind RAINBOW trial compared ramucirumab and paclitaxel to placebo and paclitaxel in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer that was refractory to or progressive after initial chemotherapy. The most common (>5% incidence) Grade >3 adverse events occurring at a higher rate on the ramucirumab-plus-paclitaxel arm compared to the control arm included neutropenia, leukopenia, hypertension, fatigue/asthenia and abdominal pain.

"We are excited to see a second positive Phase III trial of ramucirumab in gastric cancer demonstrating an improvement in both overall survival and progression-free survival, as stomach cancer is a difficult-to-treat disease that remains a major health problem worldwide and the prognosis for patients diagnosed with advanced gastric cancer is poor," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology. 

The first positive study, REGARD, showed single-agent ramucirumab improved overall survival and progression-free survival in patients with advanced gastric cancer who have had disease progression after initial chemotherapy.  There are no agents specifically approved in the U.S. or EU for advanced gastric cancer patients in this setting.

Lilly plans to present data from the RAINBOW trial at an upcoming scientific meeting and intends to submit an application for ramucirumab in combination with paclitaxel to regulatory authorities.

A separate global Phase III study of ramucirumab in women with locally recurrent or metastatic breast cancer, ROSE, did not meet its primary endpoint of progression-free survival.  This trial is being conducted with the international cancer research group TRIO (Translational Research in Oncology).The randomized, double-blind trial, also known as TRIO-012, compared ramucirumab and docetaxel to placebo and docetaxel as a first-line treatment in patients with unresectable, locally recurrent or metastatic HER2-negative breast cancer.  The primary endpoint of progression-free survival in this study favored ramucirumab but was not statistically significant.  The interim analysis for overall survival showed no benefit for ramucirumab.  The most common (>5% incidence) Grade >3 adverse events occurring at a higher rate on the ramucirumab-plus-docetaxel arm compared to the control arm included fatigue/asthenia, neutropenia, febrile neutropenia, hypertension and stomatitis.

"Cancer is complex and patients with different tumor types may have varied responses due to distinct tumor biologies and individual patient characteristics.  Unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer," said John Mackey, MD., principal investigator of the ROSE/TRIO-012 study and professor of oncology, University of Alberta.

Lilly and TRIO will work together to determine next steps for patients enrolled in this ramucirumab breast cancer study, and plan to present data from this trial at an upcoming scientific meeting.  Lilly does not plan to submit an application to regulatory authorities for ramucirumab in the first-line treatment of locally recurrent or metastatic HER2-negative breast cancer based on the results from this study. 

"We are disappointed that this breast cancer trial did not meet its primary endpoint.  However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program. We are looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014," said Dr. Gaynor.

Notes to EditorAbout the RAINBOW trialRAINBOW is a global, randomized, double-blind, placebo-controlled Phase III study of ramucirumab and paclitaxel compared to placebo and paclitaxel in patients with advanced (locally advanced, unresectable or metastatic) gastric cancer (including adenocarcinomas of the gastro-esophageal junction) refractory to or progressive after initial chemotherapy containing platinum and fluoropyrimidine.  Initiated in 2010, the global study randomized a total of 665 patients across 27 countries in North America, South America, Europe, Australia and Asia.  The primary endpoint of the RAINBOW trial is overall survival and secondary endpoints include: progression-free survival; time to progressive disease; objective response; quality of life; and safety.

About the REGARD trialREGARD is a global, randomized, double-blind Phase III study of ramucirumab and best supportive care compared to placebo and best supportive care as treatment in patients with advanced gastric cancer (including adenocarcinomas of the gastro-esophageal junction) following progression after initial chemotherapy. In total, 355 patients were randomized in 29 countries.

About Gastric Cancer Gastric cancer is the fourth most common cancer in the world and the second-leading cause of cancer-related death.[i]  There were approximately one million new cases of stomach cancer worldwide in 2008 (640,000 men, 348,000 women), with approximately 736,000 deaths (463,000 men, 273,000 women), making it the third-leading cause of cancer death globally in men and the fifth in women.[ii] Stomach cancer is more prevalent in countries outside the U.S. and EU.[iii]

Gastric cancer is a disease in which cancer cells form in the lining of the stomach. It develops slowly, usually over many years and often goes undetected.[iv] As the stomach cancer advances, it can travel through the bloodstream and spread to organs such as the liver, lungs and bones.[v]

The most common type of stomach cancer is called adenocarcinoma, which starts from one of the common cell types found in the lining of the stomach.[vi] Other types include: lymphoma, gastrointestinal stromal tumor and carcinoid tumor. [v]

About the ROSE trial and TRIOThe ROSE trial, also known as TRIO-012, is a global, randomized, double-blind Phase III study of ramucirumab and docetaxel compared to placebo and docetaxel in patients with human epidermal growth factor receptor-2 (HER2)-negative, unresectable, locally recurrent or metastatic breast cancer.  Initiated in 2008, the global study randomized a total of 1,144 patients at more than 230 sites in 23 countries.  The primary endpoint of the ROSE trial is progression-free survival and secondary endpoints include: overall survival; time to progression; percentage of participants with objective response; duration of response; immunogenicity; quality of life; and safety.

TRIO is an academic global network of investigators capable of providing rapid accrual and high quality data in oncology clinical trials. TRIO has selected dedicated investigators from around the world to participate in pivotal trials of new cancer agents in breast cancer and other cancer settings. TRIO has been successful in maintaining a strong and enthusiastic network by offering innovative and exciting science through its own translational research. TRIO also has an operations infrastructure that uses comprehensive pharmaceutical industry standards and procedures. TRIO was incorporated as a Canadian not-for-profit entity in 1999.  Additional information about TRIO is available at www.trioncology.org.

About RamucirumabRamucirumab is designed to directly inhibit angiogenesis, a process by which blood vessels supply blood to tumors. Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor (VEGF) receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.

Ramucirumab, which Lilly gained through its 2008 acquisition of ImClone Systems, is being investigated in clinical trials as a single agent and in combination with other anticancer therapies for the treatment of multiple types of cancer. In total, there are six global Phase III trials of ramucirumab – one each in breast, colorectal, hepatocellular (liver) and lung cancer, and two in gastric (stomach) cancer.

About Lilly OncologyFor more than five decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com

About Eli Lilly and CompanyLilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.  Additional information about Lilly is available at www.lilly.com.

P-LLY(Logo:  http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

This press release contains forward-looking statements about the potential of ramucirumab as a treatment of various cancers 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. There is no guarantee that future studies will be positive or that ramucirumab will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

[i] Globocan 2008 Cancer Fact Sheet. Stomach Cancer Incidence and Mortality Worldwide in 2008. http://globocan.iarc.fr/factsheets/cancers/stomach.asp. (Accessed: September 25, 2013).

[ii] Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61:69.

[iii] American Cancer Society, "Learn About Cancer: What are the Key Statistics about Stomach Cancer?" Updated: February 22, 2013; http://www.cancer.org/Cancer/StomachCancer/DetailedGuide/stomach-cancer-key-statistics, (Accessed: September 25, 2013).

[iv] American Cancer Society, "Learn About Cancer: Stomach Cancer," Updated: February 22, 2013; http://www.cancer.org/Cancer/StomachCancer/index, (Accessed: September 25, 2013).

[v] American Cancer Society, "Learn About Cancer: What is Stomach Cancer? Topics," Updated: February 22, 2013; http://www.cancer.org/Cancer/StomachCancer/DetailedGuide/stomach-cancer-what-is-stomach-cancer, (Accessed: September 25, 2013).

[vi] National Center for Biotechnology Information, "Gastric Cancer," Updated: December 15, 2011; http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001270/), (Accessed: September 25, 2013).

 Contact:Tracy Henrikson (Lilly Oncology)Neil Hochman (TogoRun)609-240-3902212-453-2067 (office)Email: tracy.henrikson@imclone.com516-784-9089 (mobile)Email: n.hochman@togorun.com


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