MILAN & DARMSTADT, Germany--()--Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced the first results from the BALI-1 study of Erbitux® (cetuximab) in the treatment of metastatic triple-negative breast cancer (TNBC), an aggressive cancer in which early relapse and metastasis are common. The data, presented during the 35th Congress of the European Society for Medical Oncology (ESMO), demonstrate that Erbitux has the potential to improve outcomes for women with this relentlessly devastating cancer.
“Erbitux is already a gold-standard treatment and preferred partner to chemotherapy in colorectal and head and neck cancers”
The randomized Phase II study showed that women treated with Erbitux in combination with chemotherapy had a significant reduction in risk of progression compared with those treated with chemotherapy alone (HR=0.675; p=0.032).1 The study also showed an improved tumor response rate (20.0% vs. 10.3%; p=0.11) in women treated with Erbitux plus chemotherapy. The chance of complete response or partial response was twice as high for patients receiving Erbitux in combination with chemotherapy (OR=2.126). Although there was a strong trend toward improved tumor response, the primary endpoint of the study, response rate, was not met.
“Triple negative breast cancer is one of the most aggressive and, unfortunately, difficult types of breast cancer to treat,” said Professor José Baselga, Principle Investigator of the BALI-1 study and Chief of the Division of Hematology/Oncology and Associate Director of the Massachusetts General Hospital Cancer Center, Massachusetts, U.S. “Hormone and chemotherapies used to manage other types of breast cancer simply don’t work against TNBC, so the possibility that Erbitux may, in the future, provide a new therapy option for the disease is extremely encouraging.”
Breast cancer is the most common cancer among women in the Western world and its incidence is increasing.2 Approximately 15-18% of breast cancers are ‘triple negative’3 which means that they do not express receptors for estrogen, progesterone or HER2 and do thus not respond to hormone or anti-HER2 therapy. TNBC is particularly aggressive and associated with high rates of metastasis and relapse. There is a clear need for research into new treatment options for this group of breast cancer patients.
Erbitux, a monoclonal antibody, acts on the epidermal growth factor receptor (EGFR), which plays a role in TNBC. It is for this reason that the potential of Erbitux to treat TNBC is being investigated in this setting.
“Erbitux is already a gold-standard treatment and preferred partner to chemotherapy in colorectal and head and neck cancers,” said Dr. Wolfgang Wein, Executive Vice President for Oncology at Merck Serono. “We are continuing to explore the full potential of this best-in-class drug in significantly undertreated settings, in the hope that it may offer effective treatment options where there are currently none.”
Other news from Merck Serono at ESMO 2010
Please visit www.globalcancernews.com for further news about Erbitux from ESMO 2010, including:
- Early Tumor Shrinkage with 1st Line Erbitux Therapy Leads to Longest-Ever Median Survival in KRAS Wild-Type mCRC. Abstract No. 596P.
- Surveys Highlight Advancing Confidence in Erbitux as Only Targeted Treatment to Increase Survival and Potential for Cure in Head and Neck Cancer. Abstracts 1031P & 1033P.
References For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.
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 80 countries. It has been approved for the treatment of colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 77 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
- 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.
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.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of more than € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 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.
1 Baselga J, et al. ESMO Congress 2010. Abstract No: 274O.
2 Boyle R, et al. World Cancer Report 2008: WHO, International Agency for Research on Cancer.
3 Breakthrough Breast Cancer. Triple Negative Breast Cancer http://breakthrough.org.uk/our_work/our_research/researching_breast_cancer/triplenegative.html.