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New Drug: Tebentafusp-tebn for metastatic uveal melanoma

New Drug: Tebentafusp-tebn for metastatic uveal melanoma
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

Nathan P, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma

https://doi.org/10.1056/nejmoa2103485

Reviewed by Hasan Cagri Yildirim, MD on Sep 30, 2021

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