Merck: Erbitux Indication Extension Submitted for First-Line Advanced or Metastatic NSCLC in the EU

  • Submission is based on a new biomarker principle
  • Merck believes that personalizing treatment is the future of cancer therapy and is committed to making this a reality

Darmstadt, Germany, March 30, 2011 - Merck KGaA announced today that it has submitted an indication extension to the European Medicines Agency (EMA) for the approval of Erbitux® (cetuximab) in combination with standard first-line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.

The submission is based on a new biomarker analysis of EGFR expression levels in tumors of patients participating in the Phase III FLEXa study. New data, presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology in December 2010, showed that, among patients with high EGFR expression, the response rate was significantly increased by the addition of Erbitux to standard chemotherapy from 28.1% to 44.4% (p=0.002).1 Merck analyzed further clinical data for the submission and plans to present additional results at upcoming congresses.
In Europe, lung cancer is the leading cause of death from cancer, accounting for 20% of all cancer deaths (28% in men and 10% in women).2 NSCLC accounts for approximately 80% of all lung cancer cases.3 At diagnosis, most patients with NSCLC present with advanced, non-operable (also called unresectable) disease, which is associated with a very poor prognosis.4 NSCLC remains difficult to treat with very few new effective drugs identified over the last ten years. The overall five-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.5

a FLEX: First-line in Lung cancer with ErbituX

1. O'Byrne K, et al. Chicago Multidisciplinary Symposium in Thoracic Oncology 2010. Abstract No. LBOA1.
2. European Lung Foundation. www.european-lung-foundation.org/index.php?id=65.
3.D'Addario, et al. Ann Oncol 2008;19(Suppl 2):ii39-40.
4. Bunn PA, et al. Oncologist 2008;13(Suppl 1):1-4.
5. 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: 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 87 countries. It has been approved for the treatment of colorectal cancer in 87 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 84 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.

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