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Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
Date:5/15/2013

abine/cisplatin.5

"These data from the LUX-Lung 6 trial add to the growing body of knowledge for the investigational compound, afatinib, in EGFR mutation-positive advanced non-small cell lung cancer," said William Goeckeler , PhD, director, Oncology Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "This is the second Phase III trial involving afatinib in this patient population to meet its primary efficacy endpoint and to incorporate health-related quality of life measures into the study design."

The LUME-Lung 2 Clinical Trial of Nintedanib
LUME-LUNG 2 (Efficacy) Abstract: #8034
Poster Discussion:  Sunday, June 2, 11:30 AM-12:30 PM, poster board #23

This randomized, double-blinded Phase III study evaluated nintedanib plus pemetrexed compared to pemetrexed plus placebo in patients with advanced non-squamous NSCLC not responding to, or who progressed after, first-line chemotherapy.2 LUME-Lung 2 was halted at the recommendation of the Independent Data Monitoring Committee after 713 patients had been enrolled. This decision was based on the results of an interim review of efficacy (PFS) for a pre-defined futility analysis, and was not safety related. At the point of the interim review, PFS did not appear significantly improved compared to the comparator arm.

Data will be presented on the 713 patients who enrolled; results showed that the addition of nintedanib to pemetrexed improved PFS (HR=0.83, p=0.04) even though enrollment was stopped prematurely.2 Patients treated with nintedanib plus pemetrexed (n=353) lived for a median of 4.4 months before their tumor started to grow again (PFS), compared to 3.6 months for patients assigned to the pemetrexed plus placebo arm (n=360).2

A higher incidence of greater than or equal to grade 3 elevated ALT (23% versus 7%) and AST (12% versus 2%)2
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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