LUME-Lung 1 results represent the first advance in almost a decade in overall survival for patients where initial chemotherapy has failed
INGELHEIM, Germany I June 3, 2013 I 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.1These 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.”
Notes to Editors
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 3 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.
About Nintedanib*
Nintedanib* is an oral triple angiokinase inhibitor that blocks three growth factor receptors simultaneously: vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and beta), and fibroblast growth factor receptors (FGFR 1-3).2 All three receptors are crucially involved in the formation and maintenance of new blood vessels (angiogenesis); their blockade may lead to the inhibition of angiogenesis, which plays a critical role in tumour growth and spread.3,4
Nintedanib* is currently being investigated in patients with various solid tumours including advanced NSCLC, ovarian cancer, liver cancer (hepatic cell carcinoma), kidney cancer (renal cell carcinoma), and colorectal cancer.
About Lung Cancer
Lung cancer is the most common and deadly form of cancer in the world: it accounts for 1.6 million new cancer cases annually. Because of its poor prognosis, 1.38 million deaths each year are attributable to lung cancer.5 Overall, lung cancer is the cause of 18% of all cancer deaths.5 13% of all new cases of cancer are lung cancers6 and smoking is attributed as the main cause.
There are multiple types of lung cancer, and each type requires a specific treatment approach. Adenocarcinoma is the most common type of lung cancer, accounting for 48% of all NSCLC (NSCLC accounts for 85% of all lung cancers).
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.
The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. Nintedanib* (BIBF 1120), an angiogenesis inhibitor is currently in Phase III clinical development in NSCLC and ovarian cancer. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1 (Plk1), the investigational compound volasertib*, a protein that is involved in the processes of cell division. The compound is in Phase III development for acute myeloid leukaemia.
Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
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*Afatinib, nintedanib and volasertib are investigational compounds and are not yet approved. Their safety and efficacy have not yet been fully established.
References:
1 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.
2 Hilberg F, Roth GJ, Krssak M, et al. BIBF1120: triple angiokinase inhibitor with sustained receptor blockade and good anti-tumor efficacy. Cancer Res 2008;68: 4774-82.
3 Folkman N. Clinical applications of research on angiogenesis. N Engl J Med 1995;333: 1757-63.
4 Bousquet C, Lamande N, Brand M, et al. Suppression of angiogenesis, tumor growth, and metastasis by adenovirus-mediated gene transfer of human angiotensinogen. Mol Ther 2006;14:175-82.
5 Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127: 2893-917.
6 Cancer Research UK. UK lung cancer incidence. CancerStats – Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/ [Last Accessed May 2013].
7 Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2010, [Online] National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2010/, based on November 2012 SEER data submission, posted to the SEER web site, 2013. [Last Accessed May 2013].
SOURCE: Boehringer Ingelheim
