Data presented today at the 1st International Thoracic Oncology Congress Dresden (ITOCD) demonstrate that the addition of Erbitux® (cetuximab) to standard platinum-based chemotherapy in the 1st-line treatment of advanced NSCLC resulted in a significantly longer overall survival. The patient population comprising all histological subtypes - and therefore closely resembled 'real world' clinical practice.1
"In pioneering new approaches to NSCLC treatment, it is now clear that combining Erbitux, the first EGFR-targeting antibody in NSCLC, with existing chemotherapy is the key to success and provides new hope for these patients as previously we only had chemotherapy to offer to them," said Professor Robert Pirker of the University of Vienna and lead investigator of the FLEXa trial. "Unlike other targeted therapies, which either failed to yield significant benefit in clinical trials or can only be used in highly-selected patient populations, the results achieved in the FLEX trial represent major progress in the treatment of this aggressive disease."
The multinational, randomized, Phase III FLEX trial, which involved a total of 1,125 patients with stage IIIB/IV NSCLC, confirms the findings of three earlier clinical studies which all demonstrated that the addition of Erbitux to a number of different 1st-line, platinum-based chemotherapy regimens yielded 7-10% increases in tumor response rate and up to 2.7-month increases in overall survival.2-4
In FLEX, patients treated with Erbitux plus standard platinum-based chemotherapy had a median survival time of 11.3 months compared to 10.1 months in those receiving chemotherapy alone, representing a 13% reduction in the risk of death during the study (p=0.04).1 Considering that 94% of patients receiving the Erbitux combination had stage IV metastatic disease and 17% had ECOG performance status 2, this significant result is particularly important because these patients represent the real clinical practice.1 In the 84% of patients in the study who were Caucasian, the median overall survival increased from 9.1 to 10.5 months (Hazard Ratio 0.80, p=0.003).1 Within this group, patients with adenocarcinoma experienced an overall survival benefit of almost 2 months (10.3 vs 12.0 months). Across the trial population, side effects observed with the Erbitux combination were acceptable and manageable.1
The ITOCD is focused on advances that have been achieved through molecular biology research in thoracic cancer. Highlighting the relevance of the FLEX results in this context, Erbitux is the only targeted therapy to show a significant survival benefit in such a broad population of patients in the 1st-line treatment of NSCLC when added to standard chemotherapy. The results of the FLEX study supported the new license application for Erbitux in this setting submitted to the EMEA last month.
"These data reinforce that Erbitux is the only targeted regimen which has ever achieved a significant survival advantage over a cisplatinum-based chemotherapy and across all histological subtypes," said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.
Stimuvax®, a therapeutic cancer vaccine in Phase III development, will also be included in the ITOCD's scientific program. A summary of Phase II data is being presented at the congress by Dr Charles Butts from the Department of Medical Oncology, Cross Cancer Institute, Edmonton, Canada. The results found a trend in a subgroup of patients with unresectable locoregional stage IIIB NSCLC who had either responded or had stable disease after initial radio-chemotherapy and were then treated with Stimuvax; these patients experienced a doubling of overall survival from 13.3 months to 30.6 months compared to patients receiving best supportive care alone (n=35 Stimuvax, n=30 control).5 The global Phase III STARTb trial is open for recruitment and investigates Stimuvax as maintenance therapy in stage III inoperable NSCLC patients.
Lung cancer is the most common cause of cancer death in men worldwide and the second most common in women (after breast cancer).6 Approximately 975,000 men and 376,000 women die from the disease each year.7 Around 80% of lung cancer patients present with non-small-cell lung carcinoma (NSCLC),8 and approximately one-third of these patients' tumors will have advanced to the stage where surgical resection is not a viable option.9 The outlook for lung cancer patients is poor with an overall five-year survival rate of approximately 10%, which compares unfavorably with the rates associated with other tumor types such as melanoma (81%) or breast cancer (75%).10
a FLEX: First-line in Lung cancer with ErbituX
b START: Stimulating Targeted Antigenic Responses to NSCLC
References
1. Pirker R, et al. Presented in 'Targeting the Epidermal Growth Factor Receptor (EGFR): Molecular Biology and Clinical Practice - Monoclonal Antibodies' at ITOCD, Oct 3rd 2008.
2. Rosell R, et al. Ann Oncol 2008;19:362-9.
3. Butts C, et al. J Clin Oncol 2007;25:5777-84.
4. Lynch T, et al. J Thorac Oncol 2007;2(Suppl. 4):S340-1. Updated info presented at WCLC 2007.
5. Butts C. Presented in 'Novel Treatment Strategies - Vaccines' at ITOCD, Oct 4th 2008
6. World Health Organization. Fact sheet N°297: Cancer. Last accessed on Aug 4th 2008.
7. American Cancer Society Global Cancer Facts & Figures 2007. Last accessed on Sep 24th 2008.
8. D'Addario G & Felip E. Ann Oncol 2008;19 Suppl 2:ii39-40.
9. Bayman N, et al. Clin Lung Cancer 2008;9(2):92-101.
10. Sant M, et al. Ann Oncol 2003;14 Suppl 5:v61-118.
For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: globalcancernews.
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.
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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 75 countries. It has been approved for the treatment of colorectal cancer in 74 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, 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. In the European Union, the license was updated in July 2008 for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC (metastatic colorectal cancer) in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Honduras, Hong Kong, Iceland, Japan, Lebanon, Liechtenstein, Mexico, Moldova, New Zealand, Nicaragua, Norway, 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 68 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldova, 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 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. .
About Stimuvax
Merck is investigating the use of Stimuvax® (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. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc. .
START is a multi-center, randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries. For more information on the START study, or to find a participating center and eligibility criteria, go to nsclcstudy. The study is also listed on clinicaltrials. .
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®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®)..
With an annual R&D investment of around € 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. .
For more information, please visit merckserono or merck.de.
About Merck
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to subscribe.merck.de to register online, change your selection or discontinue this service. .
Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 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. .
Merck
View drug information on Erbitux; Gonal-F; Rebif.
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