Findings demonstrate that patients with metastatic colorectal cancer previously treated with chemotherapy can achieve tumor shrinkage with Erbitux which may lead to subsequent resection of their liver metastases
GENEVA, Switzerland | November 29, 2007 | Findings from a new report published in the Journal of Clinical Oncology suggest that Erbitux® (cetuximab) in combination with chemotherapy provides pretreated, unresectable patients who have liver metastases with the possibility of cure for their metastatic colorectal cancer (mCRC).1 These findings demonstrate that pretreated mCRC patients who were previously unresectable can become resectable.
“The results are particularly exciting as it is the first time that we have been able to offer resection to pretreated metastatic colorectal cancer patients,” commented Professor René Adam from the Paul Brousse Hôpital, Villejuif, Paris and lead investigator of the study. “Failure to respond to first-line treatment frequently leads to poor response rates. However, with the addition of Erbitux, not only did we achieve good response rates in pretreated patients but we were also able to convert patients from an unresectable to a resectable status, offering them their only chance for cure. Our research suggests that this is a promising oncosurgical strategy for future consideration.”
About 50% of patients with colorectal cancer will develop liver metastases during the course of the disease. Surgical resection (removal) of metastases from the liver is the only curative option in mCRC and can increase five-year survival from 5% to 50%.2 However, surgical resection is currently limited to a small proportion of patients with mCRC, predominantly due to the limited response (tumor shrinkage) to the best available chemotherapies, which prevents metastases from being shrunk to a size that allows surgical resection.
The findings were from an evaluation of 133 French patients who had either initially unresectable or recurrent mCRC and were switched to a combined therapy of chemotherapy and Erbitux due to insufficient response on their previous therapies. Overall, 9 patients responded to treatment sufficiently to allow them to be resected.
“To our knowledge this is the first time a meaningful response rate has been achieved while using resectability as the main end point in this pretreated metastatic colorectal cancer patient group,” commented Professor René Adam. “The safety of this procedure in pretreated patients was also good and without increased risk of operative mortality or liver injury.”
The findings from this report reinforce other data from randomized Phase II and III studies involving Erbitux that have demonstrated consistently high response rates and an up to three-fold higher rate of liver resection when combined with first-line irinotecan or oxaliplatin-based chemotherapy regimens.3,4,5,6 These studies have also found that treatment with Erbitux does not lead to an increased risk of surgical or post-operative complications such as bleeding or wound healing.
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, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, 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, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, 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. Adam R, et al. Hepatic Resection After Rescue Cetuximab Treatment for Colorectal Liver Metastases Previously Refractory to Conventional Systemic Therapy. J Clin Oncol 25:4593-4602.
2. Folprecht G, et al. Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates. Ann Oncol 2005;16(8):1311-9
3. Van Cutsem E, et al. ASCO 2007 (Abstract No. 4000; updated information presented)
4. Van Cutsem E, et al. ECCO 2007 (Abstract No. 3001)
5. Cervantes A, et al. (2005) Eur J Cancer Suppl 3:181 (Abstract No.642)
6. Schuch G, et al. WCGIC 2007 (Abstract No. 0-0022)
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 EUR 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.
About Merck
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 30,000 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.
SOURCE: MERCK SERONO
Post Views: 119
Findings demonstrate that patients with metastatic colorectal cancer previously treated with chemotherapy can achieve tumor shrinkage with Erbitux which may lead to subsequent resection of their liver metastases
GENEVA, Switzerland | November 29, 2007 | Findings from a new report published in the Journal of Clinical Oncology suggest that Erbitux® (cetuximab) in combination with chemotherapy provides pretreated, unresectable patients who have liver metastases with the possibility of cure for their metastatic colorectal cancer (mCRC).1 These findings demonstrate that pretreated mCRC patients who were previously unresectable can become resectable.
“The results are particularly exciting as it is the first time that we have been able to offer resection to pretreated metastatic colorectal cancer patients,” commented Professor René Adam from the Paul Brousse Hôpital, Villejuif, Paris and lead investigator of the study. “Failure to respond to first-line treatment frequently leads to poor response rates. However, with the addition of Erbitux, not only did we achieve good response rates in pretreated patients but we were also able to convert patients from an unresectable to a resectable status, offering them their only chance for cure. Our research suggests that this is a promising oncosurgical strategy for future consideration.”
About 50% of patients with colorectal cancer will develop liver metastases during the course of the disease. Surgical resection (removal) of metastases from the liver is the only curative option in mCRC and can increase five-year survival from 5% to 50%.2 However, surgical resection is currently limited to a small proportion of patients with mCRC, predominantly due to the limited response (tumor shrinkage) to the best available chemotherapies, which prevents metastases from being shrunk to a size that allows surgical resection.
The findings were from an evaluation of 133 French patients who had either initially unresectable or recurrent mCRC and were switched to a combined therapy of chemotherapy and Erbitux due to insufficient response on their previous therapies. Overall, 9 patients responded to treatment sufficiently to allow them to be resected.
“To our knowledge this is the first time a meaningful response rate has been achieved while using resectability as the main end point in this pretreated metastatic colorectal cancer patient group,” commented Professor René Adam. “The safety of this procedure in pretreated patients was also good and without increased risk of operative mortality or liver injury.”
The findings from this report reinforce other data from randomized Phase II and III studies involving Erbitux that have demonstrated consistently high response rates and an up to three-fold higher rate of liver resection when combined with first-line irinotecan or oxaliplatin-based chemotherapy regimens.3,4,5,6 These studies have also found that treatment with Erbitux does not lead to an increased risk of surgical or post-operative complications such as bleeding or wound healing.
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, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, 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, Nicaragua, Norway, Panama, Peru, the Philippines, Qatar, 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. Adam R, et al. Hepatic Resection After Rescue Cetuximab Treatment for Colorectal Liver Metastases Previously Refractory to Conventional Systemic Therapy. J Clin Oncol 25:4593-4602.
2. Folprecht G, et al. Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates. Ann Oncol 2005;16(8):1311-9
3. Van Cutsem E, et al. ASCO 2007 (Abstract No. 4000; updated information presented)
4. Van Cutsem E, et al. ECCO 2007 (Abstract No. 3001)
5. Cervantes A, et al. (2005) Eur J Cancer Suppl 3:181 (Abstract No.642)
6. Schuch G, et al. WCGIC 2007 (Abstract No. 0-0022)
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 EUR 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.
About Merck
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 30,000 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.
SOURCE: MERCK SERONO
Post Views: 119
