ImClone Systems and Bristol-Myers Squibb Company today announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX(R) (cetuximab) to include first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy (cisplatin/vinorelbine)
NEW YORK, NY, USA | December 8, 2008 | ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) to broaden the use of ERBITUX(R) (cetuximab) to include first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy (cisplatin/vinorelbine). Bristol-Myers Squibb is ImClone’s partner for ERBITUX in North America. The FDA will notify ImClone whether it has accepted the submission for review in February 2009.
"This submission reflects our continued efforts to maximize the potential of ERBITUX by broadening its approved uses to include new indications such as non-small cell lung cancer, a disease for which there are few impactful treatments and for which less than one in five advanced-stage patients currently receive biologic-based combination therapy in the first-line setting," said Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone.
"Lung cancer is the leading cause of cancer mortality for both men and women in the U.S., and there is a great unmet medical need in treating this disease," said Maurizio Voi, M.D., Executive Director, Oncology Global Medical Affairs, Bristol-Myers Squibb. "The submission of the NSCLC application to the FDA further demonstrates the companies’ commitment to bringing innovative oncology treatments to people with cancer."
The submission is based primarily on data from the pivotal, multinational FLEX (First-line in Lung cancer with ErbituX) Phase 3 study which demonstrated that the addition of ERBITUX to cisplatin/vinorelbine significantly increased overall survival in the first-line treatment of patients with advanced NSCLC when compared with cisplatin/vinorelbine alone. This improvement in overall survival, the study’s primary endpoint, was observed across all histological subtypes, patient performance status (a measure of well-being), age, previous smoking history, and gender groups.
The FLEX study, conducted by Merck KGaA, Darmstadt, Germany, ImClone’s ERBITUX partner outside of North America, enrolled more than 1,100 patients with Stage IIIB with malignant pleural effusion or Stage IV NSCLC who had not previously received chemotherapy.
For patients receiving ERBITUX in combination with cisplatin/vinorelbine, median overall survival was prolonged by 1.2 months when compared to cisplatin/vinorelbine alone (11.3 months vs. 10.1 months) with a hazard ratio (HR) of 0.871 [95% Confidence Interval (CI) = 0.762-0.996], p=0.044.
Grade 3/4 adverse events were reported in 91 percent of patients in the ERBITUX plus cisplatin/vinorelbine arm compared with 86 percent of patients in the cisplatin/vinorelbine alone arm. Grade 3/4 adverse events reported in patients in the ERBITUX plus cisplatin/vinorelbine versus cisplatin/vinorelbine alone arms included: neutropenia (53 percent vs 51 percent), febrile neutropenia (22 percent vs 15 percent), anemia (14 percent vs 17 percent), grade 3 acne-like rash (10 percent vs <1 percent), diarrhea (5 percent vs 2 percent), and infusion-related reactions (4 percent vs <1 percent). Findings from the FLEX study were presented at the American Society of Clinical Oncology (ASCO) meeting in June 2008.
Also, as previously announced, Merck KGaA submitted an application to the European Medicines Agency (EMEA) in September 2008 to broaden the use of ERBITUX to include first-line treatment of patients with NSCLC.
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. More than 161,000 deaths from lung cancer are expected to occur in 2008 – accounting for about 29 percent of all cancer deaths.
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.
About ImClone Systems
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. ImClone’s research and development programs include growth factor blockers and angiogenesis inhibitors. ImClone’s research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. Additional information about ImClone is available at www.imclone.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.
SOURCE: ImClone Systems
