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Overall survival benefit with tebentafusp in metastatic uveal melanoma

New England Journal of Medicine Sep 29, 2021

Nathan P, Hassel JC, Rutkowski P, et al. - Longer overall survival was achieved with tebentafusp, vs control therapy, in previously untreated patients suffering from metastatic uveal melanoma.

  • Tebentafusp represents a bispecific protein comprising an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100–positive cells.

  • This open-label, phase 3 trial involved 378 previously untreated HLA-A*02:01–positive patients with metastatic uveal melanoma.

  • They were randomized to receive tebentafusp (tebentafusp group) or the investigator’s choice of therapy with single-agent pembrolizumab, ipilimumab, or dacarbazine (control group), stratified based on lactate dehydrogenase level.

  • The intention-to-treat population showed 73% overall survival at 1 year in the tebentafusp group vs 59% in the control group (hazard ratio for death, 0.51).

  • Tebentafusp resulted in significantly higher progression-free survival vs the control group (31% vs 19% at 6 months; hazard ratio for disease progression or death, 0.73).

  • Cytokine-mediated events and skin-related events were the most common treatment-related adverse events with tebentafusp.

  • These adverse events infrequently resulted in treatment discontinuation (2%).

  • No treatment-related deaths occurred.

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