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Primary Progression-Free Survival Endpoint Met in Phase III Study of Nintedanib Plus Docetaxel in Second-Line Advanced NSCLC
Date:6/3/2013

RIDGEFIELD, Conn., June 3, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced  results from the Phase III LUME-Lung 1 study showing that the addition of the investigational oncology compound nintedanib* to docetaxel improved progression-free survival (PFS) – the primary endpoint – as a second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) compared to docetaxel alone.1 Secondary endpoints included overall survival (OS).1 These results will be presented today at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO).

"We are pleased to present the progression-free survival and overall survival data observed with the nintedanib/docetaxel combination in the LUME-Lung 1 clinical trial, in patients with advanced non-small cell lung cancer in the second-line treatment setting," said Berthold Greifenberg , MD, vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "These results were selected by ASCO for presentation at a late-breaking oral session at this year's annual meeting."

The trial enrolled 1,314 patients with advanced NSCLC whose disease progressed after first-line chemotherapy.1 Patients were randomly assigned to receive nintedanib plus docetaxel (n=655), a standard second-line chemotherapy, or docetaxel plus placebo (n=659).1

The primary endpoint was PFS as assessed by central independent review; results showed patients treated with nintedanib plus docetaxel lived for a median of 3.4 months before their tumor started to grow again, versus 2.7 months with docetaxel alone (HR 0.79; p=0.0019).1 

The secondary endpoint of OS was evaluated in the full study population, as well as in the sub-group of patients with adenocarcinoma histology &
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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