Chicago, USA/Darmstadt, Germany - Saturday, June 4th 2011 [ME NewsWire]
Data from a post-hoc analysis demonstrate that Erbitux delivers significant overall survival benefit in the palliative treatment of KRAS wild-type patients with non-liver limited disease
Results also reinforce that Erbitux increases complete resection rates in KRAS wild-type patients, which might offer these patients a chance of cure
ASCO Abstract Number: 3576
(BUSINESS WIRE)-- In alignment with this year’s American Society of Clinical Oncology (ASCO) Annual Meeting theme, ‘Patients, Pathways, Progress’, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the presentation of a retrospective analysis of the CRYSTAL trial demonstrating that Erbitux® (cetuximab) significantly improves outcomes in metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors, even if they have advanced metastatic disease which has spread beyond the liver.1
This analysis examined the benefits of 1st line Erbitux in combination with standard chemotherapy (FOLFIRI) in KRAS wild-type patients, dependent on metastatic site. Results showed that patients with non-liver limited disease (non-LLD) treated with Erbitux and FOLFIRI experienced a significant increase in overall survival of more than five months, compared to patients treated with chemotherapy alone (22.5 vs. 17.4 months, p=0.013). Given that the majority of mCRC patients fall into this more advanced category (approximately 70% of patients have non-LLD1,2), these results provide strong support for the value of Erbitux combination therapy in helping physicians achieve a key treatment goal for KRAS wild-type mCRC patients.
In addition, the new analysis examined the impact of Erbitux combination therapy on LLD patients’ ability to undergo potentially curative surgery (i.e. complete resection: R0). The highest R0 rate was seen in patients with LLD treated with Erbitux plus FOLFIRI, in whom a 2.58-fold increase in the chance of R0 versus CT alone while not reaching statistical significance (13.2% vs. 5.6%, odds ratio 2.58, p=0.125) was demonstrated.1 These results support previous findings from CRYSTAL and other key Erbitux trials,3 in which significant response rates and corresponding increases in R0 rates were seen across the KRAS wild-type patient population with the addition of Erbitux to standard chemotherapy.
“For most patients with advanced cancer, the chance to live longer, or even be cured, are the most important benefits a treatment can offer,” said Professor Claus Henning Köhne, lead author of the ASCO publication from the Klinikum Oldenburg, Germany. “These new findings from CRYSTAL are therefore important for both LLD and non-LLD patients, as we have a strong sign that both groups benefit from Erbitux combination therapy.”
These findings point to the growing importance of Erbitux in mCRC and the value of personalizing cancer care via a stratified medicine approach.
“In the palliation of patients where the tumor has spread beyond the liver prolonged survival is essential,” said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.
aCRYSTAL: Cetuximab combined with iRinotecan in 1st line therapY for metastatic colorectAL cancer
References
1 Köhne C-H, et al. ASCO Annual Meeting 2011; Abstract No: 3576.
2 Data on file.
3 Folprecht G, et al. Lancet Oncol 2010;11:38–47.
Please visit www.globalcancernews.com for further news about Erbitux from ASCO 2011.
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 88 countries. It has been approved for the treatment of colorectal cancer in 88 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 86 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.
March 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.
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 biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta™, tesamorelin), 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 over € 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 rheumatology.
About Merck
Merck is a global pharmaceutical and chemical company with total revenues of € 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 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
Contacts
Merck
Dr. Raphaela Farrenkopf
Phone +49 6151-72 2274
www.merck.de
raphaela.farrenkopf@merck.de
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