3-Year Overall Survival With Tebentafusp in Previously Untreated Advanced Uveal Melanoma

Source: The Asco Post, November 2023

In an analysis presented at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract LBA50) and reported in The New England Journal of Medicine by Jessica C. Hassel, MD, and colleagues, overall survival at 3 years in the phase III IMCgp100-202 trial continued to favor tebentafusp-tebn over investigator’s choice of treatment in previously untreated patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma.

The primary analysis of overall survival supported the January 2022 approval of tebentafusp in this setting (hazard ratio [HR] vs investigator choice of treatment = 0.51, 95% confidence interval [CI] = 0.37–0.71, P < .0001).

Study Details
In the open-label international trial, 378 patients enrolled between March 2017 and June 2020 were randomly assigned 2:1 to receive tebentafusp at 68 ?g weekly after step-up doses of 20 ?g on day 1 and 30 ?g on day 8 (n = 252) or investigator’s choice (n = 126) of 21-day cycles of pembrolizumab (2 mg/kg on day 1; n = 103), ipilimumab (3 mg/kg on day 1 for a maximum of four doses; n = 16), or dacarbazine (1,000 mg/m2 on day 1; n = 7). Except for ipilimumab, treatment was continued until disease progression or unacceptable toxicity.