Merck KGaA announced today that a first-line Phase III study of Erbitux(R)(cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
DARMSTADT, Germany | Apr 4, 2007 | Merck KGaA announced today that a first-line Phase III study of Erbitux(R) (cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This randomized European trial, known as EXTREME (ErbituX in first line Treatment of REcurrent or MEtastatic head & neck cancer), studied more than 400 patients treated with Erbitux in combination with either cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU compared with patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone.
“Recurring and metastatic head and neck cancers are very difficult to treat. We are delighted with these results,” said Elmar Schnee, Member of the Executive Board of Merck KGaA and CEO of Merck Serono S.A.. “These data demonstrate the therapeutic benefit of adding Erbitux to platinum-based chemotherapy in initial, first-line treatment.”
Results from this study have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.
Head and neck cancer may occur in the epithelial cells of any tissues or organs in the head and neck region excluding the eyes, brain, ears, thyroid or esophagus. Most head and neck cancers occur in the oral cavity (43%) followed by the pharynx (33%) and the larynx (24%).(1) The estimated incidence of head and neck cancers in Europe is around 140,000 annually, with over 65,000 deaths per year.(2) Currently, median survival for patients with recurrent or metastatic disease is only about six months.(3)
Notes for editors
About ERBITUX
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 five percent of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in 64 countries. It has been approved for the treatment of colorectal cancer in 63 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Serbia, Singapore, South Korea, Switzerland, Taiwan, 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, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Singapore, 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 53 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Malaysia, Mexico, Montenegro, Nicaragua, Norway, the Philippines, Serbia, Switzerland, Taiwan, Ukraine, the US and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Israel, Mexico, Nicaragua, the Philippines and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
About Merck KGaA
Merck KGaA, Darmstadt, Germany, 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 KGaA 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 KGaA has also acquired the rights for the cancer treatment UFT(R) (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck KGaA 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 Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies share rights.
SOURCE: Merck KGaA
Post Views: 120
Merck KGaA announced today that a first-line Phase III study of Erbitux(R)(cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
DARMSTADT, Germany | Apr 4, 2007 | Merck KGaA announced today that a first-line Phase III study of Erbitux(R) (cetuximab) combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This randomized European trial, known as EXTREME (ErbituX in first line Treatment of REcurrent or MEtastatic head & neck cancer), studied more than 400 patients treated with Erbitux in combination with either cisplatin plus 5-fluorouracil (5-FU) or carboplatin plus 5-FU compared with patients treated with cisplatin plus 5-FU or carboplatin plus 5-FU alone.
“Recurring and metastatic head and neck cancers are very difficult to treat. We are delighted with these results,” said Elmar Schnee, Member of the Executive Board of Merck KGaA and CEO of Merck Serono S.A.. “These data demonstrate the therapeutic benefit of adding Erbitux to platinum-based chemotherapy in initial, first-line treatment.”
Results from this study have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.
Head and neck cancer may occur in the epithelial cells of any tissues or organs in the head and neck region excluding the eyes, brain, ears, thyroid or esophagus. Most head and neck cancers occur in the oral cavity (43%) followed by the pharynx (33%) and the larynx (24%).(1) The estimated incidence of head and neck cancers in Europe is around 140,000 annually, with over 65,000 deaths per year.(2) Currently, median survival for patients with recurrent or metastatic disease is only about six months.(3)
Notes for editors
About ERBITUX
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 five percent of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in 64 countries. It has been approved for the treatment of colorectal cancer in 63 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Serbia, Singapore, South Korea, Switzerland, Taiwan, 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, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Singapore, 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 53 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Malaysia, Mexico, Montenegro, Nicaragua, Norway, the Philippines, Serbia, Switzerland, Taiwan, Ukraine, the US and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Israel, Mexico, Nicaragua, the Philippines and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
About Merck KGaA
Merck KGaA, Darmstadt, Germany, 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 KGaA 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 KGaA has also acquired the rights for the cancer treatment UFT(R) (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck KGaA 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 Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies share rights.
SOURCE: Merck KGaA
Post Views: 120
