MILAN & DARMSTADT, Germany, Monday, October 11th 2010 [ME NewsWire]:
* European survey results show marked uptake in use of Erbitux as the only treatment in 30 years to increase overall survival in 1st line recurrent and/or metastatic disease (R/M SCCHN)
* In 1st line R/M SCCHN, the use of Erbitux plus platinum-based chemotherapy (CT) almost tripled in one year
* In locally advanced disease (LA SCCHN), Erbitux use quadrupled over three years
Two sets of data were presented during the 35th ESMO Congress Poster Presentation II, on October 10, by Professor H Wilke (set one): ‘Recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): changes in 1st line treatment patterns in Europe 2008–2009’, and Professor V Budach (set two) ‘Trends in the treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) in Europe between 2006 and 2009’.
ESMO Abstract Numbers: 1031P and 1033P
(BUSINESS WIRE)-- Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced results from two surveys which further support the revolutionary role Erbitux® (cetuximab) continues to have in the treatment of head and neck cancer. Data from two key surveys, presented at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, show that Erbitux is a standard of care and preferred partner in both LA SCCHN1 and 1st line R/M SCCHN.2
“Erbitux has been valuable in advancing the treatment of head and neck cancer by enhancing symptom relief and extending life in the metastatic setting, and even providing some locally advanced patients with a chance for cure,” said Professor Jean-Louis Lefebvre, Chairman of the European Head and Neck Cancer Society (EHNS) and survey co-investigator.
Survey results in 1st line recurrent and/or metastatic SCCHN
The results from the patient-record-based survey of 256 specialists in France, Germany, Italy and Spain in the R/M setting showed that, in 2009, an Erbitux-based treatment combination was used to treat almost 60% of cases of R/M SCCHN in the 1st line setting.2 These findings reflect the impact of the pivotal Phase III EXTREME trial on everyday clinical practice. EXTREME, published in 2008, demonstrated the first significant improvement in overall survival in SCCHN in 30 years3 and Erbitux remains the only targeted therapy to offer this benefit in 1st line R/M SCCHN.
Survey results in locally advanced SCCHN
A similar survey of patient records conducted in the LA SCCHN setting, revealed:1
* Use of Erbitux treatment from 2006-2009 increased from 9.1% to 35.7%
* Erbitux has evolved to become a standard treatment
* The combination of Erbitux and radiotherapy continues to replace chemo-radiotherapy as the preferred standard treatment in LA SCCHN
“These new findings clearly show that more and more physicians are convinced by the data for Erbitux in the treatment of SCCHN and are changing the way they treat the disease. Erbitux’s position as one of the most significant innovations in this disease in over 30 years is now unquestionable,” said Dr. Wolfgang Wein, Executive Vice President for Oncology at Merck Serono.
Other news from Merck Serono at ESMO 2010
Please visit www.globalcancernews.com for further news about Erbitux from ESMO 2010, including:
* Early Tumor Shrinkage with 1st Line Erbitux Therapy Leads to Longest-Ever Median Survival in KRAS Wild-Type mCRC. Abstract No. 596P.
References
For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.
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 80 countries. It has been approved for the treatment of colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 77 countries:
* December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have failed prior irinotecan therapy. In addition, Erbitux is also approved for single-agent use in further countries.
* April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
* July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC 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.
* July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy
* In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN
* March 2010 (Japan): label extended to use in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wild-type gene [Beatrix Metzner- see comment.
Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, 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.
Merck is also investigating among other potential cancer treatments 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., Seattle, Washington, USA.
In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of more than € 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.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 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.
For more information, please visit www.merckserono.com or www.merck.de
1 Budach V, et al. ESMO Congress 2010. Abstract No: 1031P.
2 Wilke H, et al. ESMO Congress 2010. Abstract No: 1033P.
3 Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
For media enquiries, please contact:
Dr. Raphaela Farrenkopf
Phone +49 6151-72 2274
Merck KGaA
Frankfurter Strasse 250
64293 Darmstadt
Hotline +49 (0) 6151 72-5000
Global Business Unit Oncology
Tel. +49 (0) 6151 72-2274
raphaela.farrenkopf@merck.de
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