NICE recommends VARGATEF® (nintedanib*) in combination with docetaxel as an option for patients with non-small cell lung cancer of adenocarcinoma histology within its licensed indication

Boehringer Ingelheim today announced that following a review by the National Institute for Health and Care Excellence (NICE) in the UK, VARGATEF^® (nintedanib^*) in combination with docetaxel has been recommended for use within the National Health Service (NHS) in England and Wales. This is positive news for patients with locally advanced metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma histology who have had limited treatment options that have been shown to extend survival after first-line chemotherapy. Nintedanib, in combination with docetaxel, is the first and only triple angiokinase inhibitor available for EU patients with advanced NSCLC of adenocarcinoma histology after first-line chemotherapy.

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: “We are delighted with this announcement from NICE which represents an important milestone in the effort to extend survival for patients with adenocarcinoma of the lung following initial treatment with chemotherapy. The survival advantage demonstrated by VARGATEF^®, in combination with docetaxel, has been shown with a predictable and generally manageable safety profile.”

NICE has issued a Final Appraisal Determination (FAD) for VARGATEF^® and, subject to any appeal by consultees, the FAD may be used as the basis for the institute’s guidance on the use of the appraised technology in the NHS in England and Wales. Nintedanib, in combination with docetaxel, is the first and only triple angiokinase inhibitor available for EU patients with advanced NSCLC of adenocarcinoma histology after first-line chemotherapy.

Since the launch of VARGATEF^® in January 2015 it has also been:

• accepted for use without restriction within NHS Scotland, as per its licensed indication
• accepted by the Swedish Dental and Pharmaceutical Benefits Agency to be subsidised as a treatment of advanced lung cancer patients with adenocarcinoma in combination with docetaxel after first-line chemotherapy
• assessed by the German IQWiG who indicated an added benefit for the treatment of advanced lung cancer patients with adenocarcinoma in combination with docetaxel after first-line chemotherapy without brain metastases

These announcements are based on the outcomes of the LUME-Lung 1 study which demonstrated:

• nintedanib, plus docetaxel, significantly prolonged progression-free survival compared to docetaxel alone for patients with adenocarcinoma (PFS: primary endpoint; 4.0 vs 2.8 months)
• nintedanib, plus docetaxel, significantly extended overall survival to beyond one year for patients with adenocarcinoma, compared to docetaxel alone (OS: key secondary endpoint; 12.6 vs 10.3 months)
• nintedanib, plus docetaxel, enabled 1 in 4 patients with adenocarcinoma to live for at least two years after first-line chemotherapy

Nintedanib in combination with docetaxel demonstrated a generally manageable side-effect profile without further compromising patients’ overall, health-related, quality of life compared to chemotherapy alone. The most common adverse events for patients taking docetaxel vs nintedanib plus docetaxel included: nausea 18% vs 24%; vomiting 9% vs 17%; diarrhoea 22% vs 42% and liver enzymes 8% vs 29%.

Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most patients will experience disease progression during or after first-line chemotherapy and there is a significant need for new, effective second-line treatments.

VARGATEF^® was granted EU marketing authorisation in November 2014 and in combination with docetaxel is indicated for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy.

For notes to editors and references please visit:

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/03_june_2015_oncology.html

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^*Nintedanib is approved in the EU under the brand name VARGATEF^® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

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