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.
“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.”
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. The study also showed an improved tumor response rate (20.0% vs. 10.3%).
"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. Approximately 15-18% of breast cancers are 'triple negative' 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."
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