Merck: Erbitux Phase III Study - FLEX Increases Overall Survival in First-line Treatment of Non-Small Cell Lung Cancer

Merck KGaA announced today that Erbitux® combined with vinorelbine plus cisplatin met the primary endpoint of increasing overall survival compared with chemotherapy alone in a Phase III study initiated by Merck Serono

DARMSTADT, Germany | September 11, 2007 |
Merck KGaA announced today that Erbitux® (cetuximab) combined with vinorelbine plus cisplatin met the primary endpoint of increasing overall survival compared with chemotherapy alone in a Phase III study initiated by Merck Serono in patients with advanced non-small cell lung cancer (NSCLC).
This randomized multinational trial, known as FLEX (First-Line Treatment for Patients with EGFR-EXpressing Advanced NSCLC), involved patients with Stage IIIB or Stage IV non-small cell lung cancer who were randomized to treatment with chemotherapy and Erbitux or with chemotherapy alone and who had not previously received chemotherapy.

“Non-small cell lung cancer that has spread from the primary site is extremely difficult to treat so we are delighted with these results,” said Dr. Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono. “Erbitux is the first targeted agent that when combined with platinum-based chemotherapy has demonstrated a therapeutic benefit in a first-line NSCLC study that included all histological subtypes. These are important results given that recent trials involving other targeted therapies such as Tyrosine Kinase inhibitors have failed to demonstrate a benefit for patients in this setting.”

Detailed results from this study are expected to be submitted for presentation at an upcoming medical conference.

In Europe, there are approximately 400,000 new cases of lung cancer each year, accounting  for 22% of all new cancer diagnoses.1 The incidence is higher among men in eastern  countries than in western countries.2 Non-small cell lung cancer accounts for around 80% of  cancers of the lung.3 The five-year survival for patients with Stage III NSCLC who have  radiotherapy and chemotherapy is 7-17%; for Stage IV disease, overall five-year survival is 2%.4 In Europe, lung cancer is the principal cause of cancer deaths in men (22%) and the third-leading cause in women (9%).5

References:

1 Bray F, Sankila R, Ferlay J, Parkin DM. Estimates of cancer incidence and mortality in Europe in 1995. Eur J Cancer 2002;38:99-166
2 Tyczyński JE, Bray F, Parkin DM. Lung cancer in Europe. ENCR Cancer Fact Sheets. European Network of Cancer Registries. March 2002 (www.encr.com.fr/lung-factsheets.pdf; accessed 27.6.07)
3 Cancer Research UK. Types of lung cancer. September 2006. (www.cancerhelp.org.uk/help/default.asp?page=2965#non-small; accessed 27.6.07)
4 Cancer Research UK. Statistics and prognosis for lung cancer. May 2007 (www.cancerhelp.org.uk/help/default.asp?page=6747#nonsmall; accessed 27.6.07)
5 Bray F, Guerra M, Parkin DM. The comprehensive cancer monitoring programme in Europe. Eur J Public Health 2003;13(3 supplement):61-6

About the study

FLEX is a randomized Phase III study of Erbitux® plus chemotherapy (cisplatin plus vinorelbine) or chemotherapy alone in previously untreated patients with histologically or cytologically confirmed Stage IIIB with documented malignant pleural effusion or Stage IV non-small cell lung cancer, plus immunohistochemical evidence of EGFR-expression on tumor tissue, and the presence of at least one bidimensionally measurable index lesion not lying within an irradiated area. The primary endpoint was overall survival time. Other secondary endpoints included progression free survival time, response rate, safety and quality of life.

Definition of NSCLC stages IIIB and IV:

Stage IIIB:

-- no distant metastases
-- fluid collection around the lung
--more than one tumor in the affected lobe of the lung
-- cancer spread to nodes on the other side of the chest or to nodes above either collarbone
-- tumor has grown into another major structure in the chest (heart, windpipe)"

Stage IV:

Distant metastases are present (cancer has spread to another lobe of the lung from where it started or to another part of the body, for example the liver or bones)

About ERBITUX

ERBITUX® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.

Erbitux has already obtained market authorization in 68 countries. It has been approved for the treatment of colorectal cancer in 67 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Serbia, Singapore, South Korea, Switzerland, Taiwan, Thailand, Ukraine, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 60 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Serbia, Singapore, Switzerland, Taiwan, Ukraine, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Nicaragua, Panama, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur¬uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada.

Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to Please go to http://subscribe.merck.de to register online or change your selection. Discontinue this service with http://unsubscribe.merck.de.

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,214 employees in 63 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

SOURCE: MERCK KGaA

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