Erbitux Improves Survival In Metastatic Colorectal Cancer - Study Published In NEJM

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 15 Nov 2007 - 1:00 PDT

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Erbitux® (cetuximab), Merck Serono's targeted cancer therapy, offers a statistically significant improvement in median overall survival compared with best supportive care (BSC), according to research published in the New England Journal of Medicine. All patients in the study had metastatic colorectal cancer (mCRC) that had progressed with all available standard chemotherapies - irinotecan, oxaliplatin, and flouropyrimidines.1

The independent Phase III study NCIC CTG CO.17 involved 572 patients and demonstrated that treating patients with Erbitux as a monotherapy improved overall median survival by 32% - 6.1 months with Erbitux compared to 4.6 months with BSC only. The study also showed that patients treated with Erbitux had significantly improved progression free survival and a better quality of life (QoL), with less deterioration in physical function and global health status scores (p<0.05) when compared to BSC.

Derek J. Jonker, MD, Ottawa Regional Cancer Center, Ottawa, principle investigator for the study which was conducted by the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) in collaboration with the Australasian Gastro-Intestinal Trials Group (AGITG), and primary author of the New England Journal of Medicine article commented: "Evidence from this trial is extremely encouraging as it shows that Erbitux significantly increases survival and improves quality of life in these heavily pre-treated mCRC patients. The study demonstrates that Erbitux is a new standard of care for patients for whom all other standard treatment options have failed."

Wolfgang Wein, Merck Serono's Executive Vice President for Global Oncology, added: "We are extremely encouraged by the results of this study and the benefits to patients it demonstrates. Erbitux is the first and only therapy to demonstrate a survival benefit in any randomized Phase III study in a patient population where the only other option is best supportive care. This study adds to the positive results seen in other Phase III trials reported earlier this year both in first-line2 and in pre-treated3 mCRC patients. Together, these studies demonstrate that Erbitux can consistently add meaningful efficacy throughout all lines of therapy in mCRC."

More than 370,000 people develop colorectal cancer in Europe every year, accounting for 13% of the total cancer burden and around 200,000 deaths.4 Approximately 25% of patients present with metastatic disease.5 Five-year survival rates for patients with mCRC are as low as 5%.6

Notes:

BSC stands for Best Supportive Care and refers to palliation. This means optimal palliative therapy was given to patients to keep them as comfortable and symptom-free as possible. BSC helps the patient and the family cope with the condition and the treatment of it. BSC can include treatments such as antibiotics, analgesics, and psychotherapy. In this study BSC was given alone in one arm to constitute a control group and in the other arm it was given in combination with Erbitux.

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 69 countries. It has been approved for the treatment of colorectal cancer in 68 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, 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 61 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, Uruguay, 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, 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® (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.

References:

1. Jonker DJ et al. NEJM 2007; 357: 20
2. Van Cutsem E et al.Data presented at ASCO 2007, Abstract 4000
3. Sobrero AF et al. Data presented at AACR 2007 Abstract LB-2
4. Parkin DM et al. CA Cancer J Clin 2005; 55: 72-108
5. GLOBOCAN. http://www-dep.iarc.fr/
6. Argiris A et al. Cancer 2004; 101: 2222-2229

About 'Merck Serono'

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), metabolic and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®). With an annual R&D investment of € 1bn, we are committed to growing our business in specialist-focused therapeutic areas, such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

For more information, please visit http://www.merckserono.net or http://www.merck.de

About Merck KGaA

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

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 30,962 employees in 61 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.

http://www.merck.de

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