Final Overall Survival And Updated Biomarker Analysis Results From The Randomized Phase Iii Icogen Trial

ABSTRACT Purpose A total of 399 pretreated patients with advanced NSCLC were randomly assigned to receive gefitinib or icotinib in the phase III ICOGEN trial, the results of primary endpoint-PFS has been reported previously. This report presents updated efficacy and biomarker analysis results to determine the relationship between EGFR mutation and clinical outcomes. Methods EGFR mutation was evaluated by Scorpion ARMS (QIAGEN, n = 152). Overall survival was analyzed by survival analysis at 82% matutity. Results Median OS was 13.3 months for icotinib and 13.9 months for gefitinib (hazard ratio [HR] = 0.90; 95% CI, 0.79 to 1.02; P = .109). EGFR mutation rate was 43% for icotinib group and 59% for gefitinib group. Compared to wild type patients, patients with EGFR mutation had longer PFS (median, 6.2m vs. 2.3m; P = .0000) as well as OS (median, 20.5m vs. 7.7m; P = .0000). There was no significant difference of PFS or OS between two treatment groups in EGFR mutation-positive (median PFS, 7.8m vs. 5.3m for icotinib and gefitinib groups, respectively, P =.3162; median OS, 20.9m vs. 20.2m for icotinib and gefitinib groups, respectively, P =.7611.) or in EGFR mutation-negative (median PFS, 2.3m vs. 2.2m for icotinib and gefitinib groups, respectively, P =.1531; median OS, 7.8m vs. 6.9m for icotinib and gefitinib groups, respectively, P =.7885.) subgroups. Conclusion There was no statistically significant difference between icotinib and gefitinib in all patients or EGFR mutated patients. This suggests icotinib can provide similar overall survival to gefitinib. The EGFR mutation status is the strongest predictor in identifying which patients will be likely to benifit from icotinib. Disclosure All authors have declared no conflicts of interest.