Study
Open-label Phase III trial |
Untreated HLA-A*02:01-positive patients with metastatic uveal melanoma |
Tebentafusp or the investigator’s choice of therapy with single-agent pembrolizumab, ipilimumab, or dacarbazine |
Efficacy
Median OS: 21.7 vs. 16.0 months (HR: 0.51 [95% Cl, 0.37-0.71]) |
Median PFS: 3.3 vs. 2.9 months (HR: 0.73 [95% Cl, 0.58-0.94]) |
1-year OS: 73% vs. 59% (HR: 0.51 [0.37-0.71] P<0.001) |
6 months PFS: 31% vs. 19% (HR: 0.73 [0.58-0.94], P=0.01) |
Safety
Any grade AEs: cytokine release syndrome (89% vs. 3%), rash (83% vs. 24), pyrexia (76% vs. 3%), pruritus (69% vs. 21%), chills (47% vs. 3%), nausea (43% vs. 19%), fatigue (41% vs.26%), hypotension (38% vs 0%) |
N Engl J Med 2021; 385:1196-1206
{“Natahn P”,”et al.”}Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma
http://doi.org/10.1056/nejmoa2103485
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022