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  • pharmainvestor11 pharmainvestor11 Nov 13, 2008 10:57 AM Flag

    Erbitux Update in NSCLC

    Merck KGaA: Overall Survival in First-Line NSCLC Reaches 15 Months With Erbitux

    • New data from pivotal FLEX study reveal that patients treated with
    Erbitux who develop early skin rash show median overall survival of 15 months (p<0.001)
    • FLEX data reconfirm the value of adding Erbitux to platinum-based chemotherapy in the first-line treatment of patients with NSCLC

    Chicago/Darmstadt, November 13, 2008 - Data presented today at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology show that patients with non-small cell lung cancer (NSCLC) who were given Erbitux® (cetuximab) in addition to standard 1sft-line platinum-based chemotherapy lived significantly longer than those who received chemotherapy alone.

    This effect was more pronounced in patients treated with Erbitux who developed early acne-like rash, resulting in median overall survival of 15 months.

    Note that
    - the present standard of care treatment Avastin has the best OS = 12 months vs Erby 15 months.
    - US NSCLC is $2B+ market


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    • NSCLC PFS=7 months & OS=14 months with chemo+Bev+Cet

      Four drug combination helps in lung cancer-US study
      Thu Nov 13, 2008
      By Maggie Fox, Health and Science Editor

      WASHINGTON, Nov 13 (Reuters) - Combining two chemotherapy drugs with two targeted therapies was safe and appeared to help patients with advanced lung cancer live longer, U.S. researchers reported on Thursday.

      The combination of Roche and Co's Avastin, ImClone's Erbitux, carboplatin and paclitaxel appeared to add an average of two months to the lives of patients, from 12 months on average to 14 months, the team at the University of Texas M. D. Anderson Cancer Center said.

      It was the first time two targeted therapies were used together with traditional chemotherapy in this way and M.D. Anderson's Dr. Edward Kim said the Avastin and Erbitux appeared to work synergistically.

      "The rationale behind the study was the finding that Avastin enhances the efficacy of existing therapy, thereby possibly improving the carboplatin-paclitaxel-Erbitux regimen," Kim said in a statement.

      "While early, this four-drug combination seems to show promising, yet modest improvement in efficacy without compromising patients' safety," Kim added.

      He said his team would analyze the tumors to see if there were so-called biomarkers that can predict who would do best on this therapy.

      Avastin, known generically as bevacizumab, is a monoclonal antibody, a genetically engineered immune system molecule, that targets vascular endothelial growth factor or VEGF.

      Erbitux, known generically as cetuximab, is also a monoclonal antibody and angiogenesis inhibitor.

      The two older chemotherapy drugs, paclitaxel, sold under the brand name Taxol and carboplatin sold under the brand name Paraplatin, both by Bristol Myers Squibb, kill tumor cells directly.

      Kim told the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology that his team tested 110 patients with stage 3 or 4 lung cancer in a phase II safety and efficacy trial.

      The patients got six cycles of all four drugs and then as maintenance continued infusions of Avastin and Erbitux.

      Four patients died from the treatment -- Avastin is known to sometimes cause internal bleeding -- and 40 patients had the usual side effects such as nerve pain and low blood counts.

      But 53 percent had their tumors shrink and 24 percent had stable disease. On average patients enjoyed seven months before their tumors started growing (PFS=7months) again and lived 14 months.

      Patients who previously got three drugs without Avastin lived an average of 5.5 months before their tumors started to grow again and 12 months overall.

      Lung cancer is the leading cause of cancer death globally, with 1.2 million deaths a year and 114,000 annually in the United States, according to the American Cancer Society.

      While many drugs are used to treat lung cancer, they almost all stop working eventually. (Editing by Julie Steenhuysen and David Storey)

      After all chemo+Bev+Cet worked together good. Bond2 and this trial are successful but Cairo2 was not.

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