VARGATEF® plus docetaxel significantly reduced tumour burden in lung cancer patients with advanced adenocarcinoma compared to docetaxel alone

Boehringer Ingelheim today announced at the European Cancer Congress (ECC) in Vienna, Austria, further data to support the efficacy of VARGATEF^® (nintedanib^*) in combination with docetaxel for the treatment of advanced non-small cell lung cancer (NSCLC) with adenocarcinoma histology. Further analysis of the data from the pivotal LUME-Lung 1 trial showed that after first-line chemotherapy adenocarcinoma patients receiving VARGATEF^® plus docetaxel had a significantly reduced rate of tumour growth over time, compared to patients receiving docetaxel alone. At the time of treatment initiation, the average tumour size of the 658 adenocarcinoma patients who took part in the trial was 82.5mm (diameter). After six months of treatment, the adenocarcinoma patients receiving VARGATEF^® plus docetaxel experienced about 10% less tumour growth over time (9.7mm), compared to those receiving placebo plus docetaxel (tumour size at 6 months: 98.4mm placebo plus docetaxel vs 88.7mm nintedanib plus docetaxel).

Advanced adenocarcinoma patients with the poorest prognosis received an even more pronounced benefit from VARGATEF^® plus docetaxel, compared to docetaxel alone, after first-line chemotherapy:

• Adenocarcinoma patients whose disease progressed within nine months of starting first-line chemotherapy (T<9) received a 16.8mm reduction in tumour size over time after six months (tumour size at baseline: 88.3mm; tumour size at 6 months: 114.6mm placebo plus docetaxel vs 97.8mm nintedanib plus docetaxel; difference in growth over time of 13%)
• Adenocarcinoma patients who had continuously progressed during first-line therapy (PD-FLT) experienced a 19.7mm reduction in tumour size over time after six months (tumour size at baseline: 98.1mm; tumour size at 6 months: 124.7mm placebo plus docetaxel vs 105mm nintedanib plus docetaxel; a difference in growth over time of 15%)

Professor Martin Reck, lead investigator of the LUME-Lung 1 trial said, “The reduction in tumour burden seen in adenocarcinoma patients receiving nintedanib plus docetaxel is very encouraging and it is particularly positive to see the additional benefit for those patients who progress quickly when receiving first-line therapy as they often have the poorest prognosis. Tumour burden is commonly associated with clinical outcomes and as such is a relevant and valuable measurement. These latest data add to our wealth of knowledge and reiterate the efficacy of nintedanib which has previously been shown to extend overall survival to over one year for this difficult to treat cancer.”

The Phase III LUME-Lung 1 trial randomised 1,314 patients with stage IIIB/IV recurrent NSCLC to receive either VARGATEF^® plus docetaxel or placebo plus docetaxel (1:1). Tumour growth was evaluated in a planned post-hoc analysis using all available tumour measurements. Mixed-effects models were employed to measure the relationship between time from treatment initiation and tumour size (measured as the sum of longest diameter of target lesions [SLD]).

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, “The announcement of the latest data from the LUME-Lung 1 trial further illustrates how VARGATEF^® in combination with docetaxel can potentially improve the lives of lung cancer sufferers following its EU approval in 2014. We have a long-term commitment to discovering novel and innovative treatments to better the lives of patients with different types of cancer and look forward to bringing further advances in the future.”

VARGATEF^® in combination with docetaxel was approved in the EU in 2014 for use by adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. The LUME-Lung 1 study demonstrated the efficacy and safety of the treatment:

• VARGATEF^® plus docetaxel significantly prolonged progression-free survival compared to docetaxel alone for patients with adenocarcinoma (PFS: primary endpoint; 4.0 vs 2.8 months)
• VARGATEF^® 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)
• VARGATEF^® plus docetaxel enabled one in four patients with adenocarcinoma to live for at least two years after first-line chemotherapy

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

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^* Nintedanib is not approved in other oncology indications. 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.

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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