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LUME-Lung 1: Nintedanib* plus chemotherapy extends the life of lung cancer patients with adenocarcinoma
LUME-Lung 1 results represent the first advance in almost a decade in overall survival for patients where initial chemotherapy has failed

INGELHEIM, Germany - Monday, June 3rd 2013 [ME NewsWire]

(BUSINESS WIRE)-- For non U.S. Media Only

The LUME-Lung 1 Phase III clinical trial results showed that the novel investigational compound nintedanib*, an oral triple angiokinase inhibitor, extended life by 2.3 months for non-small cell lung cancer (NSCLC) adenocarcinoma patients when added to docetaxel, versus placebo plus docetaxel.1 These results will be presented today at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

LUME-Lung 1 showed an overall survival benefit for a second-line treatment which is added on to chemotherapy, compared to chemotherapy alone. Overall survival was significantly prolonged in the group of adenocarcinoma patients with nintedanib* plus docetaxel versus placebo plus docetaxel (12.6 vs. 10.3 months respectively).1

The primary endpoint of the trial was progression-free survival (PFS) in second-line treatment of NSCLC patients.1 The combination of nintedanib* plus docetaxel demonstrated a statistically significant prolonged progression-free survival (PFS), versus placebo (3.4 vs. 2.7 months, respectively) regardless of tumour histology.1

"The results of the LUME-Lung 1 trial are particularly exciting because we have not seen any advances in overall survival for NSCLC patients receiving second-line treatment in nearly ten years. Additionally, this is the first time an anti-angiogenic treatment has shown a real benefit for NSCLC patients after initial chemotherapy has failed,” commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany, and principal investigator of the LUME-Lung 1 trial. "It is important to understand that NSCLC patients have a very poor prognosis as their tumour will inevitably progress after first-line treatment. Nintedanib* may therefore provide a much-needed new option for treatment.”

The most common adverse events (AEs) in LUME-Lung 1 were gastrointestinal side effects and liver enzyme elevations which were manageable by supportive treatment or dose reduction (adverse events placebo vs. nintedanib*: nausea 18% vs. 24%, vomiting 9% vs. 17%, diarrhoea 22% vs. 42% and liver enzymes 8% vs. 29%). Withdrawal due to adverse events was similar in both arms, as were Grade 3 hypertension, bleeding or thrombosis.1

"At Boehringer Ingelheim, we recognise that lung cancer is not just one disease and we want to ensure the best outcome for patients,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "This is why we are pleased to be presenting data at ASCO on two different late-stage oncology compounds, nintedanib* and afatinib*, each addressing different unmet needs for patients with advanced lung cancer.”

*Afatinib and nintedanib are investigational compounds and are not yet approved. Their safety and efficacy have not yet been fully established.

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