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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

Cited 23 time in Web of Science Cited 27 time in Scopus
Authors

Sakai, Daisuke; Chung, Hyun Cheol; Oh, Do-Youn; Park, Se Hoon; Kadowaki, Shigenori; Kim, Yeul Hong; Tsuji, Akihito; Komatsu, Yoshito; Kang, Yoon-Koo; Uenaka, Kazunori; Wijayawardana, Sameera R.; Wacheck, Volker; Wang, Xuejing; Yamamura, Ayuko; Doi, Toshihiko

Issue Date
2017-12
Publisher
Springer Verlag
Citation
Cancer Chemotherapy and Pharmacology, Vol.80 No.6, pp.1197-1207
Abstract
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.
ISSN
0344-5704
URI
https://hdl.handle.net/10371/212804
DOI
https://doi.org/10.1007/s00280-017-3445-z
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  • College of Medicine
  • Department of Medicine
Research Area DNA 손상 반응 타겟 물질의 면역조절 효과, Effect of DNA damage response target substances on immunomodulatory action, Efficacy and biomarker validation studies of targeted therapeutics, Resistance mechanisms according to targeted therapeutics, 표적 항암제 내성 기전 연구, 표적 항암제의 효과 검증 및 바이오마커 규명

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