凯美纳(埃克替尼) ASCO 2011 Poster——ICOGEN III期.ppt

凯美纳(埃克替尼) ASCO 2011 Poster——ICOGEN III期.ppt

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A randomized, double-blind phase III study of Icotinib versus Gefitinib in patients with advanced non-small cell lung cancer ( NSCLC) previously treated with chemotherapy(ICOGEN) Y. Sun , Y. Shi, L. Zhang , X. Liu, C. Zhou, L. Zhang, D. Wang, Q. Li, S. Zhang, S. Qin, C. Hu, Y. Zhang, J. Chen, Y. Song, J. F. Feng, Y. Cheng, H. Zhang, Y. Wu, N. Xu, J. Zhou Background Icotinib (Conmana?) is a potent and selective inhibitor targeting the tyrosine kinase domain of epidermal growth factor receptor (EGFR). Of 88 kinases profiled, Icotinib powerfully inhibited EGFR and its 4 mutants, with no significant inhibition to the rest of kinases tested. Icotinib was found to have significant clinical activity in patients with NSCLC in early phase trials. This study was designed to show that Icotinib is non– inferior to Gefitinib. Objective Primary PFS between Icotinib and Gefitinib in NSCLC patients Secondary OS、ORR、DCR、TTP、HRQoL、Safety between Icotinib and Gefitinib in NSCLC patients Explatory Mutational analysis of EGFR between Icotinib and Gefitiinib in NSCLC patients Study design Figure1.Chemical Structure of Icotinib Patients and Methods Patients with NSCLC progressed after one or two lines of chemotherapies were randomized to receive Icotinib (125mg Tid) or Gefitinib (250mg Qd). The primary endpoint: PFS. The second endpoints: OS, ORR, TTP,QOL and tolerability. Mutational analysis of EGFR gene was performed using the DsX Scorpion ARMS from Qiagen Conclusion The study met the primary objective which demonstrated non-inferiority of Icotinib to Gefitinib in terms of PFS. The non-inferiority of Icotinib also extends to the secondary objectives of OS, ORR, DCR and improvement of QOL. Icotinib had a more favourable tolerability profile than Gefitinib. Similar to Gefitinib, patients with EGFR mutations respond to Icotinib much better than patients with the wild type EGFR. Figure 3.ORR and DCR between Icotinib and Gefitinib Table 1. Safety an

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