Merck Serono, a division of Merck, Darmstadt, Germany, today announced new data from the randomized Phase III EXTREME trial of Erbitux® (cetuximab) in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN), presented at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, September 28 – October 2, 2012. The results of a retrospective analysis show that treatment outcome with Erbitux in combination with cisplatin/carboplatin plus 5-FU chemotherapy seems to be independent of human papillomavirus (HPV) tumor status, when compared with chemotherapy alone in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.1 The analysis included overall survival, progression-free survival and overall response rate.
“This analysis is very interesting as it suggests that patients with recurrent and/or metastatic head and neck cancer may benefit from the addition of Erbitux to a platinum-based chemotherapy backbone, independent of HPV status,” said Dr. Amanda Psyrri, Faculty of Medicine, University of Athens, Greece, and lead author of the analysis abstract. “HPV infection is linked to an increasing global incidence in head and neck cancer, so these encouraging results are of particular significance and warrant further investigation and validation,” she added.
The EXTREME trial demonstrated the first survival advantage in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) treatment in over 30 years2 and showed that adding Erbitux to chemotherapy extended overall survival in patients without compromising the quality of this survival.3 These new HPV data reinforce the role of Erbitux as a targeted treatment that can improve outcomes for patients with head and neck cancer.1
HPV-positive status is thought to be responsible for the escalating incidence of oropharyngeal SCCHN in recent years.4 If detected early, the outlook for patients with all types of head and neck cancer is generally good. However, the vast majority of patients are diagnosed when the disease is in late stage.2
“Unfortunately, head and neck cancer is generally treated at a late stage due to delayed presentation, diagnosis and referral,” said Professor Lefebvre, President of the European Head and Neck Society (EHNS). “We are working together with other societies to address this issue and improve patient outcomes by raising awareness of the signs and symptoms of head and neck cancer, particularly among patients and referring physicians, such as family doctors and dentists.”
About EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer
The Phase III randomized EXTREME study involved 442 patients with previously untreated R/M SCCHN who were treated with either Erbitux plus platinum-based chemotherapy (chemotherapy; cisplatin or carboplatin plus infusional 5-fluorouracil) or platinum-based chemotherapy alone. The study met the primary endpoint of significantly increasing overall survival – an improvement of 2.7 months (p=0.04) was seen for patients treated with Erbitux plus platinum-based chemotherapy compared with chemotherapy alone. The median overall survival for patients in the Erbitux plus platinum-based chemotherapy arm was 10.1 months; and 7.4 months for patients treated with platinum-based chemotherapy alone. This is among the longest ever reported survival time in a Phase III trial for this patient population.
In the retrospective analysis, 196/222 (88%) patients in the Erbitux plus chemotherapy and 184/220 (84%) in the chemotherapy arm had tissue evaluable for HPV (p16). Of these, 178/196 (91%) and 162/184 (88%) respectively had HPV-negative tumors.
The toxicity profile of Erbitux in combination with platinum-based chemotherapy was manageable and consistent with the current safety information.
1. Psyrri A, et al. ESMO 2012 Congress; ESMO ID No: 1018O.
2. Vermorken JB, et al. N Engl J Med 2008;359:1116–27.
3. Mesia R, et al. Ann Oncol 2010;21(10):1967–73.
4. Westra WH. Head and Neck Pathol 2009;3:78–81.
For more information on Erbitux in colorectal and head & neck cancer, please visit: http://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 92 countries. It has been approved for the treatment of colorectal cancer in 92 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 89 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.