FDA Approves Tebentafusp-tebn for Unresectable or Metastatic Uveal Melanoma
Source: OncLive, January 2022
The FDA has approved tebentafusp-tebn (Kimmtrak) for the treatment of HLA-A*02:01–positive adult patients with unresectable or metastatic uveal melanoma.1
The regulatory decision is supported by data from the phase 3 IMCgp100-202 trial (NCT03070392), which showed that the agent resulted in a significant benefit in overall survival (OS) vs investigator’s choice of treatment, when used in the frontline setting (HR, 0.51; 95% CI, 0.37-0.71; P < .0001).
The estimated median OS in the investigative arm was 21.7 months (95% CI, 18.6-28.6) vs 16.0 months (95% CI, 9.7-18.4) in the control arm. The estimated 1-year OS rates in the tebentafusp and investigator’s choice arms were 73% (95% CI, 66%-79%) and 59% (95% CI, 48%-67%), respectively. The OS benefit with tebentafusp was generally noted across the prespecified subsets examined on the trial.