Results at ASCO Congress 2009 Highlight Merck's Leadership in Personalizing Cancer Care

  • 70 abstracts accepted for inclusion in the ASCO annual meeting

Darmstadt, Germany, May 7, 2009 - Merck KGaA, a leader in personalizing cancer care, continues to drive the global effort to ensure patients receive therapies tailored to their cancer. This approach will be the focus of the forthcoming American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida taking place from May 29 to June 2, 2009. Seventy abstracts were accepted for inclusion.

 

At the meeting, Merck’s division Merck Serono, its partners and independent researchers will be presenting new data on Erbitux® (cetuximab) from its major CRYSTAL, FLEX and EXTREME studies among many others, including data in several potential new disease areas and new information on the use of markers in predicting clinical response. The efficacy of Erbitux in combination with a broad range of standard chemotherapy regimens will also be discussed.
Elmar Schnee, member of the Merck Executive Board with responsibility for the Pharmaceuticals business sector, explains “By tailoring Erbitux treatment to patients who will most likely benefit from therapy, we enhanced the efficacy, the patient benefit and the health economic performance.”

As reported in the major Erbitux trials in metastatic colorectal cancer (mCRC), CRYSTAL and OPUS, introducing KRAS testing enhanced the patients’ chances to remain tumor-free (to 32% and 43%, respectively).1,2 Importantly, the value of the personalized medicine approach has also been validated through survival results in colorectal, lung and head and neck cancers.3-5

Erbitux was highlighted twice by ASCO in 20086 as a major clinical oncology research advance in both mCRC and non-small cell lung cancer (NSCLC). ASCO stated that KRAS status as a predictive marker of response in mCRC will, “help guide treatment for each patient, increasing efficacy while eliminating unnecessary adverse effects.” In EGFR-expressing NSCLC, the increase in overall survival achieved by adding Erbitux to chemotherapy in the FLEX trial was recognized as an advance in this difficult-to-treat cancer which is usually resistant to treatment or diagnosed at a late stage.

Merck has an ongoing commitment to the advancement of oncology treatment and is also investigating, amongst other potential cancer treatments, the use of Stimuvax (L-BLP25 cancer vaccine) in the treatment of NSCLC, and cilengitide, its novel integrin inhibitor for glioblastoma, NSCLC and squamous cell carcinoma of the head and neck.

References
1. Van Cutsem E, et al. N Engl J Med 2009;360:1408-17.
2. Bokemeyer C, et al. J Clin Oncol 2009;27(5):663-71.
3. Pirker R, et al. Lancet 2009;373(9674):1525-31.
4. Bonner JA, et al. N Engl J Med 2006;354(6):567-78.
5. Vermorken JF, et al. 2008;359(11):1116-27.
6. Winer E, et al. J Clin Oncol 2009;27(5):812-26.

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 76 countries. It has been approved for the treatment of colorectal cancer in 75 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 71 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

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone Systems, 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 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 Oncothyreon Inc., Bellevue, 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 of 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

Contact Phyllis Carter +49 6151 72-7144

Posted: May 2009

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