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Merck PETACC-8 Study of Erbitux as Adjuvant Treatment in Colon Cancer Shows no Benefit at Pre-specified Interim Analysis

Pre-specified interim analysis of Phase III pan-European trial in patients with KRAS wild-type colon cancer does not show improvements in disease free survival

Darmstadt, Germany, May 9, 2012 – Merck announced today results from an interim analysis of the Phase III clinical trial PETACC-81. The study investigated the potential clinical utility of Erbitux® (cetuximab) for the adjuvant treatment of stage III colon cancer after complete surgical removal of the primary tumor. The pre-specified interim analysis of the study did not support benefit in disease free survival for patients given Erbitux plus standard chemotherapy (FOLFOX 4) compared with patients treated with FOLFOX 4 alone. Therefore this interim analysis does not support the use of Erbitux for the adjuvant treatment of stage III colon cancer in this setting. PETACC-8 is a randomized, controlled, multinational European trial sponsored and coordinated by the Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France.

“We are disappointed not to see an improvement in disease free survival after 3.3 years of median follow up” said Professor Julien Taïeb from the Hôpital Européen Georges Pompidou, Paris, and the PETACC-8 Principal Investigator. “Unfortunately, since the introduction of FOLFOX as standard treatment, all attempts to further improve prevention of disease recurrence have proved unsuccessful. We look forward to sharing our data at future scientific congresses.”

The PETACC-8 trial was conducted in 2,559 European patients, including 1,602 whose tumors were KRAS wild-type, all with stage III colon cancer that had been fully resected (surgically removed). Patients were given either Erbitux plus FOLFOX 4 for six months or FOLFOX 4 alone. The pre-specified analysis was conducted when all patients had been followed up for a median of 3.3 years. In the adjuvant setting, the overall clinical goal is to destroy any cancer cells that may remain after the tumor has been surgically removed.

“While these results are disappointing, we continue to invest in expanding the science behind Erbitux to ensure its appropriate and safe use for patients living with cancer,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for the Merck Serono division.

Erbitux is indicated for the treatment of patients with KRAS wild-type metastatic colorectal cancer, and these results do not alter the current utility of Erbitux in its approved indications in metastatic colorectal cancer.

Results from the trial will be submitted for presentation at upcoming international scientific meetings.

Colorectal cancer is the fourth most common cancer worldwide, with an estimated incidence of more than 1.2 million cases globally.2 An estimated 609,000 deaths from colorectal cancer occur worldwide each year, accounting for 8% of all cancer deaths, and making it the fourth most common cause of death from cancer.3 Almost 60% of the cases occur in developed regions3 and incidence and mortality rates are substantially higher in men4,5 than in women6,7. In Europe alone, an estimated 432,000 people develop colorectal cancer every year2, with approximately 212,000 people dying from the disease annually.8

PETACC-8: Pan-European Trial in Alimentary traCt Cancer #8
GLOBOCAN 2008 World estimated cancer incidence, all ages: both sexes.:
GLOBOCAN Cancer Factsheets: Colorectal Cancer
GLOBOCAN 2008 Tables: Colorectum – incidence, all ages: male
GLOBOCAN 2008 Tables: Colorectum – mortality, all ages: male
GLOBOCAN 2008 Tables: Colorectum – incidence, all ages: female
GLOBOCAN 2008 Tables: Colorectum – mortality, all ages: female
GLOBOCAN 2008 Tables: Colorectum – mortality, all ages: both sexes

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit:

About FFCD
FFCD is a non profit organisation, based in France, involved in the conception, set up, analyses and publication of large clinical trials in digestive oncology. For more information, please visit

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 90 countries. It has been approved for the treatment of colorectal cancer in 90 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 88 countries.

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.

Merck is investigating among other potential cancer treatments the use of the investigational MUC1 antigen-specific cancer immunotherapy Stimuvax® (L-BLP25) in the treatment of non-small cell lung cancer. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA. In Japan, Merck entered into a co-development and co-marketing agreement for Stimuvax with Ono Pharmaceutical Co., Ltd., Osaka, Japan.

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 and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.

Posted: May 2012