Boehringer Ingelheim presents Afatinib LUX-Lung 1, 2 clinical trials results

Results from the LUX-Lung 1 trial suggest that Afatinib is highly active in late-stage patients with NSCLC1, while in the LUX-Lung 2 Phase II trial Afatinib demonstrated encouraging activity in advanced NSCLC patients that have a mutated EGF receptor.

Afatinib, which is taken as a tablet, is a next generation inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal receptor 2 (HER2) tyrosine kinase (TK) and unlike first generation TKIs irreversibly binds to EGFR/HER2.

The LUX-Lung 1 trial (Phase II b/III) compared Afatinib to placebo in patients with advanced NSCLC whose disease has progressed after receiving chemotherapy and an EGFR Tyrosine Kinase Inhibitor (gefitinib or erlotinib).

Reportedly, even though the LUX-Lung 1 trial did not meet the primary endpoint of prolonging overall survival (OS), Afatinib extended the time before the tumour progressed; specifically it led to a three-fold extension of progression-free survival (PFS, key secondary endpoint) from 1.1 months to 3.3 months over placebo.

Boehringer Ingelheim said that the results of LUX-Lung 1, in a special patient population whose cancers probably have a high incidence of EGFR mutations, have substantially contributed to better understanding of the biology of these tumours.

Lung Cancer Committee, McGill University, Canada chairman and trial investigator Vera Hirsh said that the time to deterioration, meaning the time before the symptoms get worse, was extended for some of these symptoms in the LUX Lung 1 study.

The LUX-Lung 2 results showed that the use of Afatinib led to a high rate of tumour size reduction (overall response rate of 61%) and a long delay in the progression of cancer by over 1 year (PFS of 14 months).