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Promising Cetuximab Data Presented in Patients With Advanced Lung Cancer

CHICAGO, May 31 /PRNewswire-FirstCall/ -- The investigational IgG1 monoclonal antibody ERBITUX(TM) (cetuximab), in combination with multiple standard chemotherapy agents, may have potential in treating patients with advanced non-small cell lung cancer (NSCLC), according to results from four studies presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting.

"These early findings are promising and suggest that cetuximab combined with chemotherapy may add benefit compared to chemotherapy alone," said Paul A. Bunn Jr., M.D., Grohne/Stapp Endowed Professor of Oncology, Professor of Medicine and Director of the University of Colorado Cancer Center, Denver, Colo. "Further studies will evaluate the efficacy of cetuximab in these patients."

Investigators who conducted the four studies presented the following results regarding cetuximab activity in patients with advanced NSCLC:

* In the randomized, Phase II, Merck KGaA-sponsored Lung Cancer Cetuximab Study (LUCAS), the addition of cetuximab to cisplatin and vinorelbine increased tumor response rates (53.3 percent vs. 32.3 percent) in 61 patients with chemotherapy-naive NSCLC evaluable for response.

* Findings from a Phase IB/IIA study combining cetuximab with gemcitabine and carboplatin in 35 patients demonstrated responses to treatment including 10 patients (28.6 percent) with a partial response (PR) and 21 patients (60.0 percent) with stable disease (SD). Disease control, defined as complete response (CR) plus PR plus SD, was achieved in 88.6 percent of patients. Severe hematologic toxicities included thrombocytopenia, leukopenia and anemia.

* Findings from a Phase I/II study of cetuximab combined with paclitaxel and carboplatin in 31 previously untreated patients demonstrated a PR in nine patients (29.0 percent) and SD in 11 patients (35.5 percent). Disease control was achieved in 20 patients (64.5 percent). The median overall survival was 472 days.

* A Phase II study of cetuximab in combination with docetaxel evaluated 47 patients who were chemotherapy-refractory/resistant. Responses that were reported included one patient with CR (1.9 percent), 11 patients with PR (20.4 percent) and 18 patients with SD (33.3 percent). Disease control was achieved in 55.6 percent of patients. Four patients discontinued the study due to an allergic reaction.

The most frequent non-hematologic toxicities reported in all four studies included acne-like rash, infection and fatigue.

According to the American Cancer Society, more than 169,000 Americans will be diagnosed with lung cancer this year. Approximately 155,000 Americans die from lung cancer annually. Lung cancer is the leading cause of cancer deaths.

About ERBITUX (cetuximab)
Cetuximab is an investigational IgG1 monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. Cetuximab is designed to bind to EGFR and prevent natural ligands called growth factors from binding to the receptor and inducing phosphorylation, i.e., activation of signaling to the tumor. The most common drug-related adverse events reported in clinical trials of cetuximab have been an acne-like rash and asthenia. Severe allergic reactions may occur in a small percentage of patients. Additional information about cetuximab can be found at www.cetuximab.com.

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