Gesamtüberlebensvorteil durch Tebentafusp beim metastasierten uvealen Melanom
نویسندگان
چکیده
<b>Background:</b> Uveal melanoma is a disease that distinct from cutaneous melanoma, with low tumor mutational burden and 1-year overall survival of approximately 50% in patients metastatic uveal melanoma. Data showing proven benefit systemic treatment are lacking. Tebentafusp bispecific protein consisting an affinity-enhanced T-cell receptor fused to anti-CD3 effector can redirect T cells target glycoprotein 100-positive cells. <b>Methods:</b> In this open-label, phase 3 trial, we randomly assigned previously untreated HLA-A*02:01-positive 2:1 ratio receive tebentafusp (tebentafusp group) or the investigator’s choice therapy single-agent pembrolizumab, ipilimumab, dacarbazine (control group), stratified according lactate dehydrogenase level. The primary end point was survival. <b>Results:</b> A total 378 were either group (252 patients) control (126 patients). Overall at 1 year 73% 59% (hazard for death, 0.51; 95% confidence interval [CI], 0.37 0.71; P&#x3c;0.001) intention-to-treat population. Progression-free also significantly higher than (31% vs. 19% 6 months; hazard progression 0.73; CI, 0.58 0.94; P = 0.01). most common treatment-related adverse events cytokine-mediated (due activation) skin-related melanocytes), including rash (83%), pyrexia (76%), pruritus (69%). These decreased incidence severity after first three four doses infrequently led discontinuation trial (2%). No deaths reported. <b>Conclusions:</b> Treatment resulted longer among (Funded by Immunocore; ClinicalTrials.gov number, NCT03070392; EudraCT 2015-003153-18.).
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ژورنال
عنوان ژورنال: Karger Kompass
سال: 2023
ISSN: ['2296-536X', '2296-5424']
DOI: https://doi.org/10.1159/000530582