作者
Paul Nathan, Jessica C Hassel, Piotr Rutkowski, Jean-Francois Baurain, Marcus O Butler, Max Schlaak, Ryan J Sullivan, Sebastian Ochsenreither, Reinhard Dummer, John M Kirkwood, Anthony M Joshua, Joseph J Sacco, Alexander N Shoushtari, Marlana Orloff, Josep M Piulats, Mohammed Milhem, April KS Salama, Brendan Curti, Lev Demidov, Lauris Gastaud, Cornelia Mauch, Melinda Yushak, Richard D Carvajal, Omid Hamid, Shaad E Abdullah, Chris Holland, Howard Goodall, Sophie Piperno-Neumann
发表日期
2021/9/23
期刊
New England Journal of Medicine
卷号
385
期号
13
页码范围
1196-1206
出版商
Massachusetts Medical Society
简介
Background
Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a 1-year overall survival of approximately 50% in patients with metastatic uveal melanoma. Data showing a proven overall survival benefit with a systemic treatment are lacking. Tebentafusp is a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100–positive cells.
Methods
In this open-label, phase 3 trial, we randomly assigned previously untreated HLA-A*02:01–positive patients with metastatic uveal melanoma in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator’s choice of therapy with single-agent pembrolizumab, ipilimumab, or dacarbazine (control group), stratified according to the lactate dehydrogenase level. The primary end point was overall survival.
Results
A total of …
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P Nathan, JC Hassel, P Rutkowski, JF Baurain… - New England Journal of Medicine, 2021