CHICAGO and DARMSTADT, Germany, May 31 /PRNewswire/ --

- New Data Provides the Basis for the Future Role of Erbitux (cetuximab) as a Standard in Combination With Platinum-Based Chemotherapy in the 1st-Line Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC)

- Location: Annual Meeting of the American Society of Clinical Oncology (ASCO) 2008, Chicago, USA

The addition of Erbitux(R) to a platinum-based chemotherapy significantly increased overall survival in the 1st-line treatment of NSCLC.(1) This data was presented today at the plenary session of the 44th American Society of Clinical Oncology (ASCO) congress. The new findings confirm that Erbitux is the first targeted therapy to show a significant survival benefit in NSCLC patients across all histological subtypes.

"Lung cancer is notoriously difficult to treat and these results are particularly exciting as they represent one of the most significant advancements in the treatment of NSCLC in 10 years," commented Professor Robert Pirker, lead investigator and Professor of Clinical Oncology at the University of Vienna, Austria. "This opens new 1st-line treatment options for NSCLC patients, regardless of histological type of cancer and sets a new standard in the treatment of 1st-line NSCLC."

In the pivotal multinational, Phase III FLEX(a) trial, more than 1,100 patients with stage IIIB/IV NSCLC were randomized to receive Erbitux plus standard platinum-based chemotherapy or chemotherapy alone. The results demonstrated that in the 1st-line setting, patients treated with Erbitux experienced significant benefits in overall survival. Median overall survival was prolonged by 1.2 months in the combination arm compared to those receiving chemotherapy alone (11.3 vs 10.1 months).(1)

Patients from the major treatment group (Caucasians, representing 84% of the trial population) experienced a significant increase in overall survival of 1.4 months compared to those receiving chemotherapy alone, reflected also in a hazard ratio of 0.8 (p=0.003). In this group, patients with adenocarcinoma receiving Erbitux had a survival benefit of 1.8 months compared to those in the control arm.(1)

The FLEX trial included patients with all histological subtypes, including adenocarcinoma and squamous cell carcinoma, as well as ECOG 2 patients who have much worse prognosis than patients with a better performance status. "Since 94% of patients in the Erbitux plus chemotherapy arm had stage IV metastatic NSCLC and 17% had performance status 2, these data are not only robust, but also very meaningful for the everyday clinical reality in the treatment of 1st-line NSCLC," commented Dr. Wolfgang Wein, Executive Vice President, Oncology, at Merck KGaA, Darmstadt, Germany. "This is a further verification of the outstanding quality of Erbitux specifically and the oncology program at Merck KGaA in general."

Erbitux was found to be well tolerated in the trial with manageable and expected side effects across the populations.(1)

The current standard treatment for 1st-line NSCLC includes a variety of platinum-based chemotherapy doublets.(2) To date, Erbitux is the first targeted therapy to show a significant survival benefit in a broad population of patients - including all histological subtypes - in the 1st-line treatment of NSCLC when added to standard chemotherapy. The FLEX data support the outcomes of earlier studies investigating Erbitux in combination with standard chemotherapies in the 1st-line treatment of NSCLC, in which the addition of Erbitux increased response rate and overall survival.(3),(4)

Worldwide, lung cancer is the leading cause of cancer death in men and the second leading cause of cancer death in women.(5) Approximately 975,000 men and 376,000 women die from the disease each year.(6) NSCLC accounts for around 80% of lung cancers. Most patients with NSCLC present with advanced disease which is difficult to treat.(7) The overall five-year survival rate for lung cancer is about 16%, compared to 65% for colon cancer, 89% for breast cancer and 99% for prostate cancer.(8)

(a). FLEX: First-line in Lung cancer with ErbituX References (1). Pirker R, et al. ASCO 2008;Abstract No: 3. (2). Pfister D, et al. J Clin Oncol 2004;22:330-353. (3). Butts C, et al. J Clin Oncol 2007;25:5777-5784. (4). Rosell R, et al. Ann Onc 2008;19:362-369. (5). Kamangar F, et al. J Clin Oncol 2006;24:2137-2150. (6). Global Cancer Facts & Figures 2007, American Cancer Society. (7). Corner J, et al. Thorax 2005;60(4)314-319. (8). Lung Cancer Information (, accessed May 2008).


ERBITUX(R) 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 72 countries. It has been approved for the treatment of colorectal cancer in 71 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, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, 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 65 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Lebanon, Liechtenstein, Malaysia, Mexico, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Nicaragua, 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, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and, upon approval, commercialize Erbitux. 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(R) (tegafur-uracil) - an oral chemotherapy administered with folinic acid (FA) for the 1st-line treatment of metastatic colorectal cancer.

Merck is also investigating among other cancer treatments the use of Stimuvax(R) (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 Oncothyreon Inc., Bellevue, Washington, USA.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux(R)), multiple sclerosis (Rebif(R)), infertility (Gonal-f(R)), endocrine and cardiometabolic disorders (Glucophage(R), Concor(R), Saizen(R), Serostim(R)), as well as psoriasis (Raptiva(R)).

With an annual R&D investment of around EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

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Merck is a global pharmaceutical and chemical company with total revenues of EUR 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,681 employees in 60 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.

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