Preliminary Results Of A Phase Lb Trial Of Savolitinib Combined With Gefitinib In Egfr-Mutant Lung Cancer.
JOURNAL OF CLINICAL ONCOLOGY(2016)
摘要
e20559Background: Savolitinib (AZD6094, volitinib, HMPL-504) is a potent u0026 selective small molecule MET inhibitor. In preclinical models the combination of savolitinib u0026 gefitnib was more effective than either compound alone (D’Cruz et al, 2014; Zhou et al, 2013). EGFR TKI failure is frequently attributable to MET amplification. Methods: The intent of the study is to test that NSCLC pts who progressed on previous EGFR-TKI treatment, can receive treatment with gefitinib u0026 savolitinib u0026 potentially demonstrate an improved clinical response. This study (NCT02374645) has 2 phases: safety run-in phase (n~12) u0026 expansion phase (n~20). Eligibility requires advanced EGFRm+ NSCLC, measurable disease, adequate PS (0-1) u0026 organ function, progression on any prior EGFR-TKI. MET status is not required for the safety run-in but MET amplification by tumor biopsy confirmation is mandatory in the expansion phase. Data from the safety run-in phase presented here are unvalidated u0026 preliminary. Results: As of 17 January 2016,...
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