Multinational phase 1-2 study of tebentafusp for previously treated metastatic uveal melanoma

The median overall survival after a diagnosis metastatic uveal melanoma (mUM) is shorter than one year. A multinational phase 1-2 trial evaluated the T-cell receptor/anti-CD3 bispecific protein tebentafusp for mUM, using a three-week step-up dosing regimen. This regimen allowed a 36% increase in the recommended phase 2 dose compared with weekly fixed dosing. The side-effect profile was manageable, with toxicity decreasing after the first three doses. The overall response rate was 11.9% (95% CI 4.0-25.6). The median overall survival was 25.5 months, and one-year OS rate was 67%.