LUX-LUNG 4
The phase II LUX-LUNG 4 trial gives further support to the idea that afatinib may be a good option for patients who develop that T790M resistance mutation following treatment with other TKIs. Researchers led by Nobuyuki Katakami, MD, PhD, of Kobe City Medical Center General Hospital in Kobe, Japan, treated 62 patients who were EGFR-mutation positive in the primary tumor with afatinib at 50 mg/day. Fifty-one of the patients (82.3%) qualified as having acquired resistance to erlotinib and/or gefitinib.
Of the 61 patients who were evaluable, five (8.2%) had a confirmed objective response to afatinib. The median progression-free survival was 4.4 months, with a median overall survival of 19 months. Among the afatinib-related adverse events, all patients experienced diarrhea and most (91.9%) had rash/acne; 29% of patients had an adverse event that led to discontinuation of the drug.
“The results of our trial demonstrated modest but noteworthy activity of afatinib in this difficult-to-treat population,” the authors wrote. They noted that further trials are now ongoing, including one phase IB trial testing the combination of afatinib and cetuximab(Drug information on cetuximab) in a small number of patients. “There is an increasing need to develop new molecular targeted agents that address the issue of resistance to erlotinib and/or gefitinib in patients with NSCLC who initially respond to treatment and then subsequently progress.”