FDA grants priority review to tebentafusp for metastatic uveal melanoma
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The FDA granted priority review to tebentafusp for treatment of adults with HLA-A*02:01-positive metastatic uveal melanoma.
Uveal melanoma is an aggressive form of cancer for which treatment options are limited.
Tebentafusp (Immunocore Holdings) is a novel bispecific protein comprised of a soluble T-cell receptor fused to an anti-CD3 immune-effector function.
The agent targets gp100, a lineage antigen expressed in melanocytes and melanoma, according to an Immunocore-issued press release.
The FDA based priority review on findings from the randomized phase 3 IMCgp100-202 trial, which compared tebentafusp with investigator’s choice of therapy — pembrolizumab (Keytruda, Merck; 82%), ipilimumab (Yervoy, Bristol Myers Squibb; 12%) or dacarbazine (6%) — for patients with previously untreated metastatic uveal melanoma.
As Healio previously reported, the trial achieved its primary endpoint of OS.
Results presented at this year’s virtual American Association for Cancer Research Annual Meeting showed tebentafusp monotherapy conferred a statistically significant improvement in OS compared with investigator’s choice of therapy (HR = 0.51; 95% CI, 0.37-0.71).
The FDA is expected to make a decision on approval by Feb. 23.
The agency previously granted breakthrough therapy designation to tebentafusp for treatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
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