Schuler, M. and Al-Batran, S.-E. and Zvirbule, Z. and Manikhas, G. and Lordick, F. and Rusyn, A. and Vinnyk, Y. and Vynnychenko, I. and Fadeeva, N. and Nechaeva, M. and Dudov, A. and Gotovkin, E. and Pecheniy, A. and Bazin, I. and Bondarenko, I. and Melichar, B. and Huber, C. and Türeci, Ö. and Sahin, U. (2016) Final results of the FAST study, an international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without the anti-CLDN18.2 antibody IMAB362 as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma. Annals of Oncology, Vol.27 (supp_6). P.- LBA45. ISSN 0923-7534 (Print), 1569-8041 (Electronic)
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Abstract
Background: IMAB362, a chimeric monoclonal antibody that mediates specific killing of cancer cells expressing the tight junction protein Claudin18.2 (CLDN18.2) by activation of immune effector mechanisms, has demonstrated single-agent activity and tolerability in patients ( pts) with heavily pretreated gastric cancer. Methods: Pts with advanced/recurrent gastric and GEJ cancer were centrally evaluated for CLDN18.2 expression by immunohistochemistry (CLAUDETECT® 18.2 Histology Kit). Eligible pts had a CLDN18.2 expression of ≥2+ in ≥40% tumor cells, an ECOG PS of 0–1 and were not eligible for trastuzumab. Pts were randomized 1:1 to first-line EOX (epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 d1, and capecitabine 625 mg/m2 bid, d1–21; qd22) with or without IMAB362 (loading dose 800 mg/m2, then 600 mg/m2 d1, qd21). An exploratory arm (N = 85) was added to investigate a higher dose IMAB362 (1000 mg/m2) plus EOX. The primary study endpoint was PFS (Arm1 vs 2,70% power, hazard ratio [HR] 0.72, 1-sided p = 0.1). Here we present the final study results.
| Item Type: | Article |
|---|---|
| Subjects: | Oncology |
| Divisions: | Departments > Department of Oncology and Medical Radiology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 20 Sep 2017 13:58 |
| Last Modified: | 20 Sep 2017 13:58 |
| URI: | http://repo.dma.dp.ua/id/eprint/1962 |
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