New subgroup analysis of the LUX-Lung 1 trial suggests benefit from afatinib in lung cancer patients

New data to be presented show that afatinib (BIBW 2992) leads to a significant four-fold extension (4.4 months vs. 1 month for placebo) in progression-free survival, – the time before a tumour starts to grow again- , for lung cancer patients most likely to have an epidermal growth factor receptor (EGFR) mutation.

In addition, this sub-group of patients showed a trend towards prolonged overall survival. In previously presented results, the lack of overall survival seen in the overall trial population may have been due to confounding effects by the use of extensive subsequent therapies. The new updated post-hoc analysis for Boehringer Ingelheim’s investigational cancer compound afatinib comes from the phase IIb/III LUX-Lung 1 clinical trial, and is to be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology, USA 1.

The LUX-Lung 1 trial compared afatinib to placebo in patients with advanced non-small cell lung cancer (NSCLC) whose disease progressed after receiving chemotherapy and a first-generation EGFR tyrosine kinase-inhibitor (TKI), gefitinib or erlotinib. The sub-group included in the analysis to be presented comprises two-thirds of all patients from the study (391/585) who were most likely to have EGFR mutations as determined by clinical criteria based on their response to and duration of prior treatment with EGFR-TKIs.

The results presented are an update of the initial results from the LUX-Lung 1 clinical trial, which were presented at the recent European Society for Medical Oncology (ESMO) meeting in Milan 2.

Vincent A. Miller, M.D. Principal Investigator, Medical Oncologist, Memorial Sloan-Kettering Cancer Center, USA said, We continue to be encouraged by the findings of this study as we move towards personalised treatments. These data not only demonstrate the activity of afatinib, but they suggest that a certain sub-group of patients – those most likely to have EGFR mutations – may respond more positively with afatinib.

Afatinib is an investigational orally-administered irreversible inhibitor of both the EGFR and human epidermal receptor 2 (HER2) tyrosine kinases that is under development in several solid tumors including NSCLC, breast and head and neck cancer.

As part of Boehringer Ingelheim’s comprehensive LUX clinical trial programme, a phase III trial called LUX-Lung 3 has been started which will specifically investigate afatinib as a first-line treatment in patients with advanced NSCLC who harbour EGFR mutations.

About Afatinib’s clinical trial programme: LUX Trial Programme

The LUX-trial programme is a comprehensive and robust programme that comprises more than ten trials conducted across the globe, investigating afatinib in a variety of different solid tumour types, including NSCLC, breast and head and neck cancer.

The LUX-Lung 1 trial was intended to investigate afatinib as a last-line treatment option, as only very few patients receive active therapies beyond third-line in advanced NSCLC. Surprisingly, more than two-thirds of the patients received additional therapy, which, despite a substantial improvement in progression-free survival, may have confounded the overall survival results.

LUX-Lung 2 is a phase II trial evaluating afatinib in NSCLC patients with EGFR mutations, either chemotherapy naïve or after one line of chemotherapy.

In two further ongoing global phase III trials, LUX-Lung 3 and LUX-Lung 6, the efficacy and safety profile of afatinib is compared to standard chemotherapy for first-line treatment of NSCLC patients with EGFR mutations in different geographical regions.

Another trial, LUX-Lung 5, is a global phase III trial in patients previously treated with erlotinib or gefitinib. This is the first randomised phase III trial investigating whether patients who initially benefit from treatment with afatinib alone may further benefit from afatinib beyond progression when given in combination with chemotherapy.

About Lung Cancer

Lung cancer is the most common and most deadly form of cancer in the world, accounting for 1.6 million new cancer cases annually and 1.4 million deaths3 from lung cancer. Lung cancer remains an area of high unmet need, especially in its advanced stages where it is particularly aggressive and patients have limited treatment options. No approved therapy is currently available for patients with advanced lung cancer who have failed chemotherapy and progressed after treatments with EGFR TKI.

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 is committed to discovering and developing novel cancer treatments. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including various solid tumours and haematological cancers.