In alignment with the theme “Advancing quality through innovation” of the forthcoming annual meeting of the American Society of Clinical Oncology (ASCO, June 4-8 in Chicago), Merck Serono, a division of Merck KGaA, Darmstadt, Germany, will present new data from across its oncology franchise.

Data included at the meeting will highlight the impact of KRAS testing and personalized therapy, an area of innovation which the company has championed. Further, additional data for Erbitux (cetuximab) underscore the positive impact the treatment has had in metastatic colorectal cancer (mCRC) and head and neck cancer. New data for cilengitide, the first integrin inhibitor to reach phase III development in oncology, and the MEK inhibitor AS703026 will also be presented.

“Merck Serono's contribution to innovation in cancer care has enabled identification of biomarkers and treatments that have made, and will continue to make, a difference to patients,” said Dr Wolfgang Wein, executive vice president, oncology, Merck Serono. “We believe we have helped spearhead a movement within the oncology community to drive innovations that may change cancer management.”

Erbitux – driving changes in cancer care through quality and innovation: One of the most exciting recent innovations in cancer management has been the discovery of predictive biomarkers of treatment efficacy that now allow patients to receive personalized therapies that offer them the best possible treatment outcomes. Merck Serono has led the way in the development of personalized therapies, such as Erbitux, the epidermal growth factor receptor (EGFR) inhibitor. Erbitux is the first and only targeted therapy for mCRC to have provided, in combination with the standard FOLFIRI chemotherapy regimen, a significant increase in overall survival in KRAS wild-type patients compared to chemotherapy alone.

New data to be published at ASCO 2010 will reveal the global impact of KRAS testing and personalized therapy for the clinical management of mCRC. Furthermore, additional data for Erbitux will add to the growing pool of clinical evidence for the drug, underlining its role, in tandem with KRAS testing, in the optimal management of mCRC.

Erbitux is also an innovation in the treatment of head and neck cancer as the first treatment in 30 years to improve overall survival when combined with standard platinum-based chemotherapy. Data from a new pan-European survey will reveal how Erbitux has become the standard treatment for recurrent and/or metastatic head and neck cancer.

Cilengitide – phase II study update on long-term survival in glioblastoma: Merck Serono’s oncology portfolio also includes investigational compounds such as the integrin inhibitor cilengitide, hoped to be used in patients with glioblastoma, an aggressive brain tumour. New information to be presented at ASCO on this integrin inhibitor will provide the latest updates from a randomized Phase II trial in recurrent glioblastoma, including 1 - 4-year survival data.

The foundations for sustained innovation: Merck Serono continues to invest in research to uncover novel treatments to further change the landscape of cancer management. New pre-clinical data for Erbitux provide further encouraging evidence of a mode of action that includes a marked antibody-dependent cellular cytotoxicity (ADCC) activity. In addition, preliminary data from a Phase I study for Merck Serono’s MEK inhibitor AS703026 in solid tumours will be presented at the meeting.

Merck Serono’s commitment to advancing cancer care has led to collaboration with a number of leading cancer organizations, including the National Cancer Institute in the United States. These collaborations will provide an important basis for continued innovation and support Merck Serono’s goal to improve treatment and outcomes for cancer patients.

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 tumour cells and the spread of tumours to new sites. It is also believed to inhibit the ability of tumour cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumours, which appears to lead to an overall suppression of tumour 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.

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 and breast 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.