Today, Boehringer Ingelheim declared the much-awaited results of the two clinical trials of cancer compound afatinib (BIBW 2992).
The results will be presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.
Results of the ‘LUX-Lung 1’ trial show that afatinib (BIBW 2992) is extremely active in advance stage patients with NSCLC1.
The results of the ‘LUX-Lung 2’ phase II trial indicate that afatinib becomes active in late-stage NSCLC patients who have an EGF Receptor, which is mutated.
The LUX-Lung 1 trial (phase II b/III) compared afatinib to placebo in more than 580 patients with late-stage NSCLC whose disease has advanced after chemotherapy and a first-generation EGFR Tyrosine Kinase Inhibitor (gefitinib or erlotinib).
In Europe and Asia, gefitinib is used as first-line therapy for those patients, who have EGFR-mutation-positive late-stage NSCLC.
On the other hand, gefitinib can be given to limited patients in the United States under the Iressa Access Plan.
In the US, erlotinib is used only as second- and third-line therapy for patients with late-stage NSCLC.
In the study it was found that the toxicity level was less severe for erlotinib as compared to chemotherapy, barring skin rash, which was mild or moderate in severity.
The study was sponsored by Roche Pharmaceutical Company China Ltd.