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Clinical data suggest potential versatility of ALIMTA-based regimens in lung cancer

CHICAGO, June 2, 2007 -- ALIMTA (pemetrexed for injection) showed additional utility in the treatment of the most diagnosed type of cancer , according to data presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO). Results from a Phase III study suggest that a first-line ALIMTA-based regimen may deliver less toxicity than a commonly used therapy in advanced non-small cell lung cancer (NSCLC). ALIMTA is manufactured and marketed by Eli Lilly and Company.

A prospective, randomized, multicenter Phase III study was conducted to compare ALIMTA plus carboplatin with the commonly used regimen of GEMZAR (gemcitabine HC1 for injection) plus carboplatin (ASCO Abstract # 7517 ). The study, conducted by the Norwegian Lung Cancer Group, enrolled 446 chemonave patients with either stage IIIB or IV NSCLC. The primary purpose of the study was to evaluate if the ALIMTA-carboplatin combination provided increased quality-of-life benefits while offering comparable survival data. As such, the primary endpoint was quality of life (defined in the study as nausea/vomiting; dyspnea or a difficulty in breathing, and; fatigue) and the secondary endpoint was overall survival.

Thus far, 384 patients have been analyzed for toxicity and there were fewer patients in the ALIMTA arm who experienced Grade 3/4 thrombocytopenia or a low platelet level (48 vs. 107, p<.001); leukopenia or a lowering of leukocyte white blood cells (44 vs. 89, p<.001), and; granulocytopenia or a lowering of granulocyte white blood cells (78 vs. 98, p=.02). More patients in the GEMZAR arm received transfusion of platelets (5 vs. 19, p=.02). At this point, no difference in survival has been observed.

The patients in this study received a comparable quality-of-life benefit whether they received ALIMTA and carboplatin or GEMZAR and carboplatin, said Bjrn Henning Grnberg, M.D. of St. Olavs University Hospital in Norway and the studys principal investigat
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Contact: Neil Hochman
n.hochman@cprworldwideusa.com
212-453-2067
CPR Worldwide
2-Jun-2007


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