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Published on 14 October 2013

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Boehringer Ingelheim submits nintedanib for European approval

 

 

Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency for the approval of its oral triple angiokinase inhibitor nintedanib, in combination with docetaxel, for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.
Nintedanib, when added to chemotherapy, is the first lung cancer treatment that extended patient survival beyond one year in a broad population of adenocarcinoma patients, after initial chemotherapy had failed.(1)
“Improving patients’ lives remains at the forefront of Boehringer Ingelheim’s commitment to evidence based progress in the treatment of cancer.” said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “We are proud that nintedanib, a compound out of our innovative oncology research programme, is the second compound in our portfolio to be filed with the European Medicines Agency.”
Lung cancer causes more deaths than any other cancer and only approximately one out of six patients survive five years from diagnosis.(2) Adenocarcinoma is the most common type of lung cancer and more than two-thirds of patients are diagnosed at a late stage when curative treatment is no longer feasible. Ultimately, all patients with advanced adenocarcinoma will progress and require second-line treatment.(3)
The EU Marketing Authorization Application for the approval of nintedanib is based on the international, double-blind, Phase III LUME-Lung 1 trial, which was the first trial to show a survival benefit of an add-on treatment in a broad second line adenocarcinoma patient population versus an active comparator (standard-of-care/chemotherapy). In this trial in advanced NSCLC patients, 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, reducing the risk of renewed tumour growth by 21%.(1)
Overall survival was significantly prolonged in adenocarcinoma patients treated with nintedanib plus docetaxel versus placebo plus docetaxel (12.6 vs. 10.3 months respectively).(1) The results demonstrated that patients with adenocarcinoma who have failed initial treatment with chemotherapy received on average a 20% extension of overall survival.
In addition, the data demonstrated that the earlier adenocarcinoma patients failed first line chemotherapy, the bigger the benefit nintedanib provided, as patients who progressed within 9 months (T<9 months) after start of their first-line treatment, achieved a median overall survival benefit of 3 months (10.9 vs. 7.9 months).(4)
The trial results showed patients benefitted from the additional efficacy of nintedanib without further impacting their quality of life. The most common adverse events (AEs) in LUME-Lung 1 were gastrointestinal side effects and reversible liver enzyme elevations which were manageable by supportive treatment or dose reduction (adverse events nintedanib* vs. placebo: nausea 24% vs. 18%, vomiting 17% vs. 9%, diarrhoea 42% vs. 22% and liver enzyme elevation 29% vs. 8%). Withdrawal due to adverse events was similar in both arms, as were Grade 3, bleeding or thromboembolic events.(1)
Nintedanib is an oral triple angiokinase inhibitor which targets the three receptors crucially involved in angiogenesis and tumour growth. Boehringer Ingelheim endeavours to make nintedanib available to patients around the world. Further submissions worldwide are planned.
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. Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2010, 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.
  3. Cancer Research UK. CancerStats key facts on lung cancer and smoking. CancerStats – Key Facts 2009. [Online] Available at: http://info.cancerresearchuk.org/cancerstats/types/lung/ [Last Accessed April 2009].
  4. Mellemgaard A et al. Analysis of overall survival in adenocarcinoma NSCLC patients receiving second-line combination treatment with nintedanib (BIBF 1120) + docetaxel in the LUME-Lung 1 trial: a randomised, double-blind, placebo-controlled phase III study. Oral Presentation at the European Cancer Congress 2013.


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