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Lilly Announces Results From Lung Cancer Study
Date:9/6/2012

INDIANAPOLIS, Sept. 6, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small cell lung cancer (NSCLC) who were randomized to receive a combination of ALIMTA® (pemetrexed for injection) with bevacizumab (AVASTIN®) and carboplatin induction followed by ALIMTA plus bevacizumab maintenance–the ALIMTA arm–compared to the combination of paclitaxel with bevacizumab and carboplatin followed by bevacizumab maintenance–the paclitaxel arm.

The study did meet one of its secondary endpoints of improved progression-free survival for the ALIMTA arm. Results will be presented on September 7 at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

"Phase II results with this combination were promising and we were hoping to demonstrate an improvement in survival for nonsquamous NSCLC patients, so we are disappointed with the results of this trial," said Allen S. Melemed, M.D., M.B.A., senior medical director with Lilly Oncology. "POINTBREAK did show an improvement in progression-free survival, though this did not translate to an overall survival advantage."

Patients with previously untreated stage IIIB/IV nonsquamous NSCLC and a performance status of 0-1 (n=939) were randomized to receive ALIMTA (500 mg/m2) + carboplatin (AUC 6) + bevacizumab (15 mg/kg), along with dexamethasone and folic acid and vitamin B12 supplementation (n=472) or paclitaxel (200 mg/m2) + carboplatin (AUC 6) + bevacizumab (15 mg/kg), with dexamethasone (n=467). First-line treatments were conducted every three weeks for up to four cycles. Patients whose disease did not progress following first-line treatment received either maintenance of ALIMTA plus bevacizumab (n=292) o
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