Boehringer Ingelheim initiates global Phase III study investigating nintedanib in patients with colorectal cancer

-- LUME-COLON 1 will evaluate the efficacy and safety of nintedanib in specific patients with metastatic colorectal cancer (mCRC) whose disease has progressed on previous treatment

-- This study will build on the established clinical trial program for nintedanib in oncology including colorectal and lung cancers

-- Study will enroll more than 750 patients at 150 sites worldwide, with locations in the U.S., Europe and Asia

News provided by

Boehringer Ingelheim

Oct 21, 2014, 08:00 ET

RIDGEFIELD, Conn., Oct. 21, 2014 /PRNewswire/ -- Boehringer Ingelheim today announced enrollment of the first patient in a new global Phase III study in patients with metastatic colorectal cancer (mCRC). Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. Prognosis is very poor for patients with mCRC with fewer than 10% surviving for more than five years after diagnosis.

LUME-COLON 1 [ClinicalTrials.gov identifier: NCT02149108] is a double-blind, randomized, placebo-controlled study designed to evaluate the safety and efficacy of nintedanib plus best supportive care (BSC), versus placebo plus BSC, after previous treatment with standard chemotherapy and biological agents. This new study will build on previous Phase I/II studies evaluating nintedanib in mCRC. Nintedanib is an investigational compound in mCRC; its safety and efficacy have not been established.

"Based on previous clinical studies with nintedanib, BI will initiate the LUME-COLON 1 study to evaluate this compound as a potential treatment option for patients with refractory colorectal cancer," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "Patient needs are the driving force behind BI's innovation in cancer research, and the initiation of this global Phase III study represents our commitment to addressing a critical need in the colorectal cancer community."

For patients diagnosed early with localized CRC, the five-year survival rate can be as high as 93%, but for those with mCRC, prognosis is very poor, with a five-year survival rate of less than 10%. Effective screening and early diagnosis are critical to reduce the burden of disease, but there is also an urgent need to develop new treatments for patients with advanced disease.

LUME-COLON 1 will enroll more than 750 patients with mCRC whose disease has progressed on previous treatment and will be conducted at 150 sites worldwide, with locations in the U.S., Europe and Asia, among others. Patients will receive either nintedanib plus BSC, or matching placebo plus BSC. BSC is defined as the best palliative care per investigator decision. The co-primary endpoints will be progression-free survival (PFS), evaluated by blinded review, and overall survival (OS). The secondary endpoints are objective tumor response rate and disease control rate.

About Nintedanib in Oncology
Nintedanib is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptor (FGFR) signaling pathways, the three receptors crucially involved in angiogenesis and tumor growth. Growing scientific evidence shows these three different angiokinase receptors play an important role not only in angiogenesis, but also in tumor growth and metastasis.

Nintedanib is currently being investigated in patients with various solid tumors including Phase III studies in advanced NSCLC, colon cancer (metastatic colorectal cancer) and ovarian cancer, and also in Phase II studies in mesothelioma, kidney cancer (renal cell carcinoma) and liver cancer (hepatic cell carcinoma).

About Nintedanib Regulatory Status in Oncology
In the U.S., nintedanib is an investigational compound in oncology and is not approved.

In the EU, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of nintedanib in combination with docetaxel for the second-line treatment of advanced non-small cell lung cancer (NSCLC) of adenocarcinoma histology after failure of first-line chemotherapy.

About Colorectal Cancer
Colorectal cancer is a cancer in the colon or rectum (parts of the large intestine). Like other cancers, colorectal cancer starts in a small area but can spread to other parts of the body to form metastatic tumors. Symptoms of colorectal cancer typically include rectal bleeding and anemia which are sometimes associated with weight loss and changes in bowel habits. Some colorectal cancers occur due to lifestyle, increasing age or underlying genetic causes.

Colorectal cancer is the third most common cancer in the world, with nearly 1.4 million new cases diagnosed each year. It is predicted that this number will increase to 2.4 million cases each year by 2035. In the U.S., an estimated 136,830 cases of colorectal cancer will be diagnosed in 2014 alone.

About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to discover and develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

For more information, please visit www.us.boehringer-ingelheim.com.

Contact:
Paul Wynn
Public Relations
Boehringer Ingelheim
Pharmaceuticals, Inc.
Office: 203-798-4887
Mobile: 203-482-4512
Email: [email protected]

SOURCE Boehringer Ingelheim