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A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer

 Daisuke Sakai  ;  Hyun Cheol Chung  ;  Do-Youn Oh  ;  Se Hoon Park  ;  Shigenori Kadowaki  ;  Yeul Hong Kim  ;  Akihito Tsuji  ;  Yoshito Komatsu  ;  Yoon-Koo Kang  ;  Kazunori Uenaka  ;  Sameera R. Wijayawardana  ;  Volker Wacheck  ;  Xuejing Wang  ;  Ayuko Yamamura  ;  Toshihiko Doi 
 Cancer Chemotherapy and Pharmacology, Vol.80(6) : 1197-1207, 2017 
Journal Title
 Cancer Chemotherapy and Pharmacology 
Issue Date
Adult ; Aged ; Antibodies, Bispecific/therapeutic use* ; Antibodies, Monoclonal, Humanized/therapeutic use* ; Asian Continental Ancestry Group ; Disease-Free Survival ; Female ; Humans ; Male ; Middle Aged ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/pathology
Antibodies, monoclonal, humanized ; Clinical trial ; LY2875358 ; MET protein, human ; Phase II ; Stomach neoplasms
PURPOSE: Mesenchymal-epithelial transition factor (MET) is expressed in gastric cancer and associated with poor clinical outcomes. We assessed activity, safety, and pharmacokinetics of emibetuzumab, a bivalent monoclonal anti-MET antibody that blocks ligand-dependent and ligand-independent MET signaling. METHODS: This non-randomized, single-arm, Phase 2 study enrolled Asian patients with MET diagnostic positive advanced gastric adenocarcinoma. Emibetuzumab (2000 mg, intravenous) was given on days 1 and 15 (28-day cycle). The primary endpoint was 8-week progression-free survival rate. Secondary objectives included safety, pharmacokinetics, overall survival, and change in tumor size. RESULTS: Tumors from 65 patients were immunohistochemically screened to enroll 15 MET diagnostic positive patients (23% positivity; 8 Japanese, 7 Korean; 10 male). Eight-week progression-free survival rate was 0.47 (70% CI, 0.33-0.59). Disease control rate was 40% (target lesion decreases, three patients; no complete/partial responses according to RECIST). Median overall survival was 17.1 weeks (95% CI, 6.3-not achievable). No serious emibetuzumab-related adverse events or new safety signals emerged. Grade ≥ 3 possibly drug-related adverse events were hyperkalemia, hyponatremia, and hyperuricemia (one each). Emibetuzumab's pharmacokinetics profile was similar to that observed previously. MET expression and clinical outcomes were not obviously associated. CONCLUSION: Emibetuzumab was well tolerated with limited single-agent activity in advanced gastric adenocarcinoma.
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정현철(Chung, Hyun Cheol) ORCID logo https://orcid.org/0000-0002-0920-9471
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