Data published today in The Lancet demonstrate that Erbitux® (cetuximab) in combination with standard platinum-based chemotherapy significantly increased median overall survival (OS) in the 1st-line treatment of patients with non-small cell lung cancer (NSCLC).1 The results from the FLEXa trial also showed that the addition of Erbitux improved both response rate and time-to-treatment failure, with an acceptable safety profile, thus supporting the use of Erbitux as an exciting potential new standard treatment option for these patients.1

"We are very encouraged by the findings of the FLEX trial. This is the first time that a clinically significant overall survival benefit has been demonstrated for a targeted agent in a phase III study, which included patients of all histological subtypes," said Professor Robert Pirker, lead investigator of the FLEX trial and Professor of Medicine and Program Director for Lung Cancer, Medical University of Vienna, Austria. "In addition, patients receiving Erbitux who developed rash during the first cycle of treatment experienced an outstanding median overall survival of 15 months. This is very exciting, as this 1st-cycle rash can now be considered as a clear signal that these patients are likely to benefit most."

FLEX was a multinational, open-label, randomized, controlled phase III trial that involved a total of 1,125 chemotherapy-naïve patients, randomized to receive either chemotherapy plus Erbitux (557 patients) or chemotherapy alone (568 patients). In addition to the significant increase in OS from 10.1 to 11.3 months (p=0.04; hazard ratio (HR) 0.87), the study found that the addition of Erbitux led to the following key outcomes:1,2

- Increase in tumor response rate (RR) from 29% to 36% (p=0.01)
- Increase in 1-year survival rate from 42% to 47%

"With Erbitux already licensed for the 1st-line treatment of both metastatic colorectal cancer and head and neck cancer, we are excited that the publication of this latest trial data highlights the potential of Erbitux in the 1st-line treatment of NSCLC," said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA. "The statistically significant efficacy in the total FLEX trial population, coupled with the outstanding 15 month overall survival in those patients who developed 1st-cycle rash, opens the door for a new treatment strategy in NSCLC."

Statistically, lung cancer causes more deaths in men worldwide than any other tumor type, causing approximately 975,000 deaths per year. After breast cancer, it is also a leading cause of mortality from cancer in women (approximately 376,000 deaths reported globally per year).3,4 NSCLC accounts for around 80% of all cases of lung cancer,5 and the growth of approximately one-third of these tumors will have advanced to the point where surgical resection is no longer possible.6 Lung cancer patients have a poor prognosis, with only around 10% of patients surviving for five years. This survival rate compares unfavorably with the rates regularly now being achieved with other tumor types such as melanoma (81%) or breast cancer (75%).7

a FLEX: First-Line ErbituX in lung cancer

References

1. Pirker R, et al. Lancet 2009;373:1525-31.
2. Gatzemeier U, et al. Data presented at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology, Chicago, IL, 13-15 Nov 2008; Abstract No: 8.
3. World Health Organization. Fact sheet N°297: Cancer. Last accessed on 9 Feb 2009.
4. American Cancer Society Global Cancer Facts & Figures 2007. Last accessed on 9 Feb 2009.
5. D'Addario G & Felip E. Ann Oncol 2008;19 Suppl 2:ii39-40.
6. Bayman N, et al. Clin Lung Cancer 2008;9(2):92-101.
7. Sant M, et al. Ann Oncol 2003;14 Suppl 5:v61-118.

Source
Erbitux

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