(CHICAGO, IL) – Icotinib can provide overall survival (OS) benefits similar to gefitinib in patients with advanced non–small-cell lung cancer (NSCLC), according to final OS and updated biomarker analysis results from the randomized phase 3 ICOGEN trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.

Reported earlier were results of the primary endpoint of progression-free survival (PFS) for ICOGEN, the first prospective head-to-head phase 3 trial of EGFR-TKIs, which enrolled 399 patients with advanced NSCLC. This report represents the final OS and biomarker analysis results, said lead author Yan Sun, MD, Cancer Hospital, of the Chinese Academy of Medical Sciences, Beijing. The study randomly assigned patients who had progressed after one or two lines of chemotherapy to icotinib 125mg 3 times daily or gefitinib 250mg once daily.

Median OS was 13.3 months for icotinib and 13.9 months for gefitinib (P=.5724, log-rank). The EGFR mutation rate was 43% in the icotinib group and 59% in the gefitinib group. In EGFR mutants, median OS was 20.9 months for icotinib and 20.2 months for gefitinib; for wild-type, median OS was 7.8 months vs. 6.9 months, respectively. There was no statistically significant difference in OS between icotinib and gefitinib in patients with either mutated or wild-type EGFR, Dr. Sun reported. “Similar to gefitinib, the EGFR mutation status is the strongest predictor in identifying which patients will be likely to benefit from icotinib.”

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Fewer patients received treatments after disease progression in the icotinib group (56 of 199) than in the gefitinib group (70 of 196). No significant differences were observed in OS between the two treatment arms across different clinical subgroups (ie, stage, gender, performance status, or smoking status); however, the nonadenocarcinoma subgroup was significant for icotinib vs. gefitinib (P=.0347). .

Based on PFS results, icotinib was approved for second- and third-line therapy for NSCLC in China in 2011. A meeting with the U.S. Food and Drug Administration to discuss icotinib’s Investigational New Drug application is scheduled for July 2012, Fenlai Tan, MD, PhD, Vice President & Director of R&D, Zhejiang Beta Pharma Inc., told ChemotherapyAdvisor.