Merck KGaA Presented New Data On the Combination of Erbitux with Standard First-Line Therapy in Patients with NSCLC, Merck KgaA
Release Date: 2009-08-02
San Francisco, CA, USA / Darmstadt, Germany, August 1/2, 2009 – New data from a meta-analysis of trials evaluating the addition of Merck KGaA’s Erbitux® (cetuximab) to standard first-line chemotherapy in patients with non-small cell lung cancer (NSCLC) was presented today at the International Association for the Study of Lung Cancer’s 13th World Conference on Lung Cancer (WCLC) in San Francisco.The meta-analysis included four randomized Phase II/III clinical trials with a total of 2,018 patients across all histologies.1,2,3,4,5 The analysis showed the benefit of Erbitux when added to standard first-line platinum-based chemotherapy for overall survival progression free survival and overall response rate (overall survival p=0.010; progression-free survival p=0.036, overall response rate p<0.001) compared to chemotherapy alone.1
“The meta-analysis showed the benefit for Erbitux for all investigated endpoints across a broad patient population in the first-line NSCLC setting,” said Professor Nick Thatcher, Christie Hospital NHS Trust, Manchester, UK. “The survival benefit, seen irrespective of which standard chemotherapy regimen was used, shows Erbitux may have an important role in the treatment of NSCLC.”
“This meta-analysis shows significant results across all efficacy endpoints, including response rate, progression-free survival and overall survival, in trials that include all histological types of NSCLC for Erbitux in combination with standard platinum doublets adding further evidence to the already published results of the FLEXa study," said Dr. Wolfgang Wein, Executive Vice President Oncology of the division Merck Serono.
In Europe, lung cancer is the leading cause of death from cancer, accounting for 20% of all cancer deaths (28% in men and 10% in women).6 NSCLC accounts for approximately 80% of all lung cancer cases.7 At diagnosis, most patients with NSCLC present with advanced, non-operable (also called unresectable) disease, which is associated with a very poor prognosis.8 The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.9
Erbitux is already established as a standard in the treatment of metastatic colorectal cancer and squamous cell carcinoma of the head and neck.
Merck has submitted an application to the European Medicines Agency (EMEA) to license Erbitux for first-line treatment of NSCLC. Following the negative decision of the CHMP Merck Serono has requested re-examination of this opinion.
| Type: | NORMAL |
| Company: | Merck KgaA |
| Country: | Germany |