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Merck at ASCO 2007: Spectrum of Studies Reinforces Promise of,Erbitux for Colorectal and Head and Neck Cancer Patients

CHICAGO, DARMSTADT, Germany, June 5, 2007 – This year’s American Society of Clinical Oncology (ASCO) meeting in Chicago sees a wealth of promising new data presented regarding Merck KGaA’s targeted cancer therapy Erbitux® (cetuximab), further demonstrating the consistent efficacy and versatility of this agent in both first-line and subsequent treatment of metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN).

Two new studies presented at the meeting validate the role of Erbitux as an effective first-line treatment in mCRC patients, when used in conjunction with two different types of chemotherapy treatment. The CRYSTAL(a) trial, a phase III study of Erbitux plus FOLFIRI (irinotecan-based therapy) compared with FOLFIRI alone, met the primary endpoint of significantly increasing median duration of progression-free survival in patients with previously untreated mCRC. This randomized, controlled international trial studied over 1,000 patients and demonstrated a statistically significant increase of progression-free survival in the Erbitux/FOLFIRI group (8.9 months) compared with the FOLFIRI group (8 months) (p=0.0479). However, this is a point estimate; more importantly, the overall curve showed a 15% reduction in the risk of metastatic colorectal cancer growing or spreading. The study also achieved its secondary endpoint of significantly increasing response rate (tumor shrinkage by 50% or more) (47% in the Erbitux plus FOLFIRI group compared to 39% in the FOLFIRI alone group). Furthermore, in a subgroup analysis, patients who had liver metastases only had the highest PFS (11.4 months with Erbitux vs. 9.2 months in the control arm) and a 36% reduction in the risk of metastatic colorectal cancer growing or spreading. The number of complete resections of the metastases in the subgroup who had liver metastases only was more than double with Erbitux plus FOLFIRI vs. control arm (9.8% versus 4.5%). The nu mber of complete resections in the overall population was three times higher in the Erbitux plus FOLFIRI arm.

“These encouraging results indicate that we have a new first-line treatment option for metastatic colorectal cancer,” said Eric Van Cutsem, MD, PhD, a professor at University Hospital Gasthuisberg in Leuven, Belgium, and lead author of the study. “These findings are remarkable because they point towards the potential for this combination to provide a cure for those patients who were able to undergo a complete resection.”

These results were supported by the findings of the OPUS(b) study. Erbitux plus FOLFOX (oxaliplatin-based therapy) was compared with FOLFOX alone to measure overall response rate (tumor shrinkage by 50% or more). Response rate was found to be 46% in the Erbitux arm compared with 36% in the oxaliplatin-only arm. The safety profile of Erbitux in combination with chemotherapy was manageable and consistent with the current safety information.

Overall, these first-line studies demonstrate that, when added to current standard chemotherapy, Erbitux significantly increases response and resection rates, which in turn, significantly increases the chance of cure for mCRC patients.

In recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) – which is notoriously difficult to treat – first-line Erbitux combined with platinum-based chemotherapy met the primary endpoint of increasing overall survival. This phase III randomized controlled European trial, known as EXTREME(c), studied more than 400 patients treated with Erbitux in combination with either cisplatin- or carboplatin-based therapy compared with patients treated with platinum-based therapy alone. The trial represents a significant breakthrough and the first time in 35 years that a survival benefit has been demonstrated in this group of patients in a randomiz ed Phase III trial.

As well as first-line use, new findings were also presented at ASCO on the use of Erbitux in previously treated patients. New data from the phase III EPIC(d) study, which compared Erbitux plus irinotecan-based therapy with irinotecan-based therapy alone in mCRC patients who had failed first-line treatment with oxaliplatin-based chemotherapy, showed that health-related quality of life was significantly improved in the Erbitux arm, along with progression-free survival and response rate. Using a validated Quality of Life assessment tool, a statistically significant difference in favor of the Erbitux arm was seen in 10 of the 15 symptom scales, including pain (p<0.0001), nausea (p<0.0001) and global health status (p=0.047).

“The first set of data from the EPIC trial demonstrated that progression-free survival and tumor shrinkage increased significantly when Erbitux was administered to this patient population. It is therefore very encouraging to see from this new data, a significant clinical advantage with Erbitux according to subjective as well as objective parameters,” said lead investigator Professor Alberto Sobrero, Hospedale San Martino, Genova, Italy. “For mCRC patients, feeling better while reaping the benefits of targeted therapy is clearly of great importance.”

The Latin American LABEL(e) study demonstrates the therapeutic potential of Erbitux in a heavily pre-treated patient population, 24% of which had received three or more prior therapies for mCRC. In this single arm study, Erbitux plus irinotecan achieved an overall response rate of 27%, a median progression-free survival duration of more than 4 months, and an overall median survival of 9.7 months, confirming the consistent activity of Erbitux seen in previous studies.

“We are delighted with the results of these trials presented at ASCO,” said Dr Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono – a division of Merck KGaA, Darmstadt, Germany. “We believe we have reached a milestone in oncology. Erbitux consistently adds meaningful efficacy throughout all lines of mCRC therapy. The increased resection rates we observed suggest a high potential to provide a cure for those patients. The results also highlight how extensively Erbitux has advanced the treatment of patients with head and neck cancer, where Erbitux shows benefits in all lines of treatment. For the first time in 35 years, a significant survival benefit has been demonstrated by adding Erbitux to standard platinum-based chemotherapy in first-line treatment.”

In addition to these efficacy trials, studies have been carried out on infusion-related reactions and dosing. New findings from the MABEL(f) study, also presented at ASCO, suggest that the type of pre-medication given to mCRC patients might impact on the occurrence of infusion-related reactions (IRRs) associated with Erbitux plus irinotecan therapy. The data show that the addition of corticosteroids to antihistamines may reduce IRRs but, importantly, achieves this without altering anti-tumor efficacy.

Finally, evidence exists to confirm a correlation between the incidence of skin reaction and response to treatment when patients are treated with Erbitux. The EVEREST(g) study examined the effect of Erbitux dose escalation on mCRC patients who experienced no or mild skin reaction when treated with the standard dose of Erbitux (250 mg/m2) for 3 weeks. The study showed that increasing the dose of Erbitux incrementally up to 500 mg/m2/week can lead to a tumor response in patients who may not respond to the standard dose.

More than 370,000 people develop colorectal cancer in Europe every year, accounting for 13% of the total cancer burden and around 200,000 deaths.(1) Approximately 25% of patients present with metastatic disease.(2) Five-year survival rates for patients with mCRC are as low as 5%.(3)

Head and neck c ancer may occur in the epithelial cells of any tissue or organ in the head and neck region excluding the eyes, brain, ears, thyroid or esophagus. Most head and neck cancers occur in the oral cavity (43%) followed by the pharynx (33%) and the larynx (24%).(4) The estimated incidence of head and neck cancers in Europe is around 140,000 annually, with over 65,000 deaths per year.(5) Currently, median survival for patients with recurrent or metastatic disease is only about six months.(6)

(a) CRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer
(b) OPUS: OxaliPlatin and cetUximab in firSt-line treatment of mCRC
(c) EXTREME: ErbituX in first line Treatment of REcurrent or MEtastatic head & neck cancer
(d) EPIC: European Prospective Investigation of Cancer
(e) LABEL: Latin American ErBitux prE-License study
(f) MABEL: Monoclonal Antibody ErBitux in a European Pre-License Study
(g) EVEREST: Evaluation of Various ErBitux REgimens by means of Skin and Tumour biopsies

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 66 countries. It has been approved for the treatment of colorectal cancer in 65 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Lebanon, Malaysia, Mexico, Montenegro, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Serbia, Singapore, South Korea, Switzerland, Taiwan, Thailand, Ukraine, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, Lebanon, Mexico, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 55 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Israel, Kazakhstan, Malaysia, Mexico, Montenegro, Nicaragua, Norway, the Philippines, Russia, Serbia, Singapore, Switzerland, Taiwan, Ukraine, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Mexico, Nicaragua, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.

Merck KGaA, Darmstadt, Germany, licensed the right to market Erbitux outside the US and Canada from ImClone Syst ems Incorporated of New York in 1998. In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems. Merck KGaA 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 KGaA 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 KGaA 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 Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies share rights.


Parkin DM et al. CA Cancer J Clin 2005; 55: 72-108.
Argiris A et al. Cancer 2004; 101: 2222-2229.
Parkin DM et al. CA Cancer J Clin 2005; 55; 72-108.
Argiris A et al. Cancer 2004; 101: 2222-2229.

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Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 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.


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