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Cetuximab Data Demonstrate Improved Overall Survival in First-Line Treatment of Advanced Non-Small Cell Lung Cancer

NEW YORK--(BUSINESS WIRE)--May 31, 2008--ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced results that show the addition of ERBITUX(R) (cetuximab) to platinum-based chemotherapy significantly increased overall survival in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), when compared with platinum-based chemotherapy alone. This improvement in survival was observed across all histological subtypes, patient performance status (a measure of well-being), age groups, previous smoking history, and gender. Results from the landmark Phase 3 clinical trial were presented today during a plenary session at the 44th Annual Meeting of the American Society of Clinical Oncology in Chicago.

The pivotal, multinational study (Abstract #3), known as FLEX (First-line in Lung cancer with ErbituX) was planned and conducted by Merck KGaA, Darmstadt, Germany, and enrolled more than 1,100 patients with Stage IIIB or Stage IV NSCLC who had not previously received chemotherapy. Unlike previous pivotal studies of monoclonal antibodies in NSCLC, the FLEX study enrolled patients with a broad range of performance capabilities and histological subtypes - reflective of physicians' everyday practice. For patients receiving ERBITUX in combination with chemotherapy, median overall survival was prolonged by 1.2 months when compared to chemotherapy alone (11.3 months vs 10.1 months) for an hazard ratio of 0.871 (95% CI = 0.762-0.996), p=0.044.

"Lung cancer is notoriously difficult to treat and these results are particularly exciting as they represent a significant advancement in the study of non-small cell lung cancer," commented Professor Robert Pirker, lead investigator and Professor of Internal Medicine at the University of Vienna, Austria. "If approved, this will open new first-line treatment options for patients with non-small cell lung cancer regardless of histological subtypes, and may set a new standard in the first-line treatment of this disease."

"Based on these results, ERBITUX is now the first anti-EGFR (epidermal growth factor receptor)-targeted therapy to improve overall survival for the initial treatment of non-small cell lung cancer as well as the first monoclonal antibody to improve survival across all histological subtypes, when added to platinum-based chemotherapy," said Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs, Bristol-Myers Squibb. "This is also now the third tumor type where ERBITUX has demonstrated an improvement in survival."

"We look forward to submitting a supplemental biologics license application, or sBLA, later this year for ERBITUX to be used in the first-line treatment of patients with non-small cell lung cancer on the basis of the FLEX study results," said Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone. "Obtaining this sBLA is an important step in the companies' efforts to maximize the potential of ERBITUX through additional approvals for new indications and earlier-stage settings."

"The lung cancer community is extremely encouraged by the FLEX data which indicate that ERBITUX improved overall survival in a 'real world' non-small cell lung cancer patient population - as this is a disease that kills more people in the United States each year than all the other major cancers combined," said Laurie Fenton Ambrose, President of Lung Cancer Alliance (www.lungcanceralliance.org).

Details of the Study Results
In the FLEX trial, patients with Stage IIIB or Stage IV NSCLC were randomized to receive either ERBITUX in combination with platinum-based chemotherapy, cisplatin/vinorelbine (n=557), or platinum-based chemotherapy alone (n=568). Ninety-four percent of patients in the ERBITUX plus chemotherapy arm had Stage IV (metastatic) NSCLC and 17 percent had an Eastern Cooperative Oncology Group (ECOG) performance status of 2, which is indicative of extensive tumor burden and an overall poor prognosis. The primary endpoint was overall survival.

With regard to safety, grade 3/4 adverse events were reported in 91 percent of patients in the ERBITUX plus chemotherapy arm compared with 86 percent of patients in the chemotherapy alone arm. Grade 3/4 adverse events reported in patients in the ERBITUX plus chemotherapy versus chemotherapy alone arms included: neutropenia (53 percent vs 51 percent,), febrile neutropenia (22 percent vs 15 percent), anemia (14 percent vs 17 percent), acne-like rash (10 percent vs 0.2 percent), diarrhea (5 percent vs 2 percent), and infusion-related reactions (4 percent vs less than 1 percent).

About Lung Cancer
The American Cancer Society estimates that in the United States, more than 215,000 people will be diagnosed with lung cancer in 2008, which accounts for about 15 percent of all cancer diagnoses. Approximately 87 percent of these patients will be diagnosed with NSCLC, with many being diagnosed with locally advanced or metastatic disease. Lung cancer is the leading cause of cancer-related death in men and women, with more than 161,000 deaths expected to occur in 2008 - accounting for about 29 percent of all cancer deaths. In 2008, it is estimated that more Americans will die from lung cancer than breast, prostate, and colorectal cancers combined.

About ERBITUX(R) (Cetuximab)
ERBITUX (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumor cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, ERBITUX can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that ERBITUX inhibits the growth and survival of tumor cells that express the EGFR. No anti-tumor effects of ERBITUX were observed in human tumor xenografts lacking EGFR expression.

Squamous Cell Carcinoma of the Head and Neck (SCCHN)
ERBITUX, in combination with radiation therapy, is indicated for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

Colorectal Cancer
ERBITUX, as a single agent, is indicated for the treatment of EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens. ERBITUX, as a single agent, is also indicated for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan-based regimens.

ERBITUX, in combination with irinotecan, is indicated for the treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. The effectiveness of ERBITUX in combination with irinotecan is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal carcinoma.

For full prescribing information, including boxed WARNINGS regarding infusion reactions and cardiopulmonary arrest, visit https://www.erbitux.com/.

Source: ImClone Systems Incorporated and Bristol-Myers Squibb Company

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