Boehringer LUX-Lung 3 Phase III trial meets primary endpoint

The study showed that lung cancer patients taking the irreversible ErbB family blocker as a first-line treatment, lived for almost one year before their disease progressed (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on standard chemotherapy (pemetrexed / cisplatin).

The study reported that patients taking afatinib with EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations studied in the trial) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

Boehringer Ingelheim oncology clinical development and medical affairs vice president Berthold Greifenberg said the data from LUX-Lung 3 show that in patients with EGFR genetic mutations, afatinib demonstrated a significant and clinically meaningful delay in the progression of NSCLC, compared with combination pemetrexed and cisplatin.

"These results add to the growing body of evidence supporting EGFR testing as an opportunity to inform and personalize the treatment of patients with EGFR mutation-positive NSCLC," Greifenberg added.

Ddiarrhea (95%), rash (62%), and paronychia (57%) were the most common drug-related adverse events observed in the afatinib treatment arm where as nausea (66%), decreased appetite (53%), and vomiting (42%) were the most common drug-related adverse events observed in the chemotherapy arm.