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.”
About the LUME-Lung 1 trial
LUME-Lung 1 is a randomised, double-blind, Phase III study comparing nintedanib* plus docetaxel in patients with locally advanced/metastatic NSCLC after first-line therapy, with placebo plus docetaxel. The study included 1,314 patients, in Europe, Asia and South Africa, randomised to receive nintedanib* 200 mg twice daily plus docetaxel 75mg/m2 once a day, for three weeks (n=655) or placebo plus docetaxel (n=659).
LUME-Lung 1 is part of the wider Boehringer Ingelheim LUME-Lung Phase III programme for nintedanib*, investigating the safety and efficacy of nintedanib* in NSCLC patients after first line chemotherapy treatment. Approximately 2,000 patients were enrolled, making this one of the largest Phase III study programmes in this NSCLC patient population to date.
- Reck M et al. Nintedanib (BIBF 1120) + docetaxel in NSCLC patients progressing after first line chemotherapy: LUME Lung 1, a randomized, double-blind phase 3 trial. Oral Presentation at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), Chicago, IL, USA 31 May – 4 June 2013.