Immunocore announces UK MHRA accepts MAA for tebentafusp in metastatic uveal melanoma.

Tebentafusp is also being reviewed in the UK under the FDA Project Orbis initiative, which enables concurrent review by the health authorities in participating partner countries.

As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp. In the United States, the BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program.

The regulatory submissions for tebentafusp are based on data from the randomized Phase III IMCgp100-202 clinical trial evaluating tebentafusp in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be frequently insensitive to other immunotherapies. In the final study analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 [95% CI (0.37, 0.71); p< 0.0001] over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).