CHICAGO, IL— First-line afatinib is associated with prolonged survival in treatment-naïve patients with advanced non-small cell lung cancers (NSCLC) that harbor Del19-mutant epidermal growth factor receptor (EGFR), confirms a pooled analysis of data from two large phase 3 trials. The analysis was presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.

Afatinib “significantly improved OS [overall survival] in patients with advanced NSCLC harboring EGFR Del19 compared with chemotherapy, in two randomized trials,” concluded James Chih-Hsin Yang, MD, PhD, of the National Taiwan University Hospital in Taipei, Taiwan. “First-line afatinib should be the standard of care for EGFR Del19 patients.”

The pooled analysis is the first report that genotype-directed therapy for patients with an EGFR-mutation can improve survival, Dr. Yang said.

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Dr. Peter YuJames Chih-Hsin
Yang, MD, PhD

“There was no significant difference in OS of patients with L858R mutations,” however, cautioned Dr. Yang. “Del19 and L858R patients are two distinct populations and should be studied separately in the future.”

Nevertheless, he said that afatinib “remains a treatment option” for EGFR L858R patients.

Afatinib is approved by the U.S. Food and Drug Administration as an oral, irreversible ErbB family blocker of EGFR, HER2, ErbB3 and ErbB4.

The coauthors pooled data for 631 patients with stage IIIb/IV NSCLC who participated in the open-label phase 3 LUX-Lung 3 and LUX-Lung 6 trials, which compared afatinib with gemcitabine-cisplatin chemotherapy. The pooled analysis included data for 419 patients who received afatinib and 212 patients who received chemotherapy.

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For patients with Del19, median OS was significantly higher among those administered afatinib (n=236; median OS, 31.7 months) than those receiving chemotherapy (n=119; median OS, 20.7 months; hazard ratio, 0.59; 95% CI: 0.45-0.77; P = 0.0001).


  1. Yang JCH, Sequist LV, Schuler MH et al. Abstract 8004. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.