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Alimta(®)-based Regimens Continue to Support Patients with Devastating Disease

Sept 5, 2007 Eli Lilly and Company

Data Affirm Benefit of ALIMTA(®) (pemetrexed for injection) for Patients With Malignant Pleural Mesothelioma

SEOUL, Sept. 4 /PRNewswire-AsiaNet/ -- Data from two large, open-label studies show patients experienced one-year survival rates above 50 percent when treated with ALIMTA(R) (pemetrexed for injection) or ALIMTA-based regimens for malignant pleural mesothelioma (MPM) in both a first-line and second-line setting. The study results affirm important efficacy and safety benefits for Eli Lilly and Company's ALIMTA, the only-known agent to demonstrate a survival benefit in this often difficult-to-treat disease primarily associated with exposure to asbestos. The data were presented today at the 12th World Conference on Lung Cancer.

One of the largest studies undertaken in the treatment of mesothelioma, the triple-arm, open-label, multicenter, first-line study (WCLC Abstract # C5-01) treated patients with ALIMTA as a single agent, while the other two arms evaluated ALIMTA in combination with either cisplatin or carboplatin. All three arms demonstrated clinically similar one-year survival rates (58.6% for ALIMTA alone; 63.1% for ALIMTA+cisplatin, and; 64.0% for ALIMTA+carboplatin). The ALIMTA plus platinum combination arms achieved higher response rates than ALIMTA alone (10.5% for ALIMTA; 26.3% for ALIMTA+cisplatin, and; 21.7% for ALIMTA+carboplatin). All 2,023 patients treated in the first-line setting had a histologic or cytologic diagnosis (pa-tients cells were reviewed under a microscope) of MPM that was not amenable to curative surgery.

An open-label, multicenter study (WCLC Abstract # C5-03), evaluated the results from 988 patients who were treated in a second-line setting for MPM with ALIMTA as a single agent, ALIMTA+cisplatin or ALIMTA+carboplatin after being previously treated with chemotherapy. All three arms demonstrated a significant one-year survival rate (54.7% for ALIMTA alone; 67.9% for ALIMTA+cisplatin, and; 65.5% for ALIMTA+carboplatin). Patients treated with ALIMTA in combination with a platinum-based chemotherapy demonstrated higher response rates (12.1% for ALIMTA; 23.8% for ALIMTA+cisplatin, and; 16.8% for ALIMTA+carboplatin). The most common grade 3/4 toxicities on both studies were leukopenia, neutropenia, thrombocytopenia and anemia.

"The initial clinical trial results for ALIMTA in malignant pleural mesothelioma were definitely considered a medical breakthrough when they were unveiled just three years ago," said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader for Lilly. "It is encouraging that these open-label studies show real world patient treatment outcomes that are consistent with those from the controlled clinical research environment. In my opinion, this is clinically meaningful information to the practicing oncologist."

ALIMTA was approved by both the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) in 2004 in combination with cisplatin for the treatment of MPM. To date, ALIMTA has been approved in more than 85 countries in combination with cisplatin for the treatment of MPM.