The Food and Drug Administration has accepted for Priority Review the Biologics License Application for tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma.

Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp is designed to specifically target gp100, a lineage antigen expressed in melanocytes and melanoma. The investigational product utilizes the Company’s ImmTAC technology platform to redirect and activate T cells to recognize and kill tumor cells. 

The application is supported by data from the multicenter, open-label, randomized phase 2 IMCgp100-202 trial (ClinicalTrials.gov Identifier: NCT03070392) that assessed the efficacy and safety of tebentafusp in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma. Patients were randomly assigned to receive tebentafusp administered via intravenous infusion or investigator’s choice (dacarbazine, ipilimumab, or pembrolizumab) until confirmed disease progression or unacceptable toxicity. The primary endpoint was overall survival, defined as the time from patient inclusion to date of death due to any cause up to 40 months.

Findings demonstrated that treatment with tebentafusp monotherapy was associated with a clinically and statistically significant superior overall survival benefit in the intent-to-treat population (hazard ratio 0.51; 95% CI, 0.37-0.71; P <.0001) compared with the investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).


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A Prescription Drug User Fee Act (PDUFA) target date of February 23, 2022 has been set for the application.

Reference

Immunocore announces that US Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for tebentafusp in metastatic uveal melanoma. News release. Immunocore Holdings Limited. Accessed August 24, 2021. https://www.globenewswire.com/news-release/2021/08/24/2285396/0/en/Immunocore-Announces-that-U-S-Food-and-Drug-Administration-and-European-Medicines-Agency-accept-Biologics-License-Application-and-Marketing-Authorization-Application-for-Tebentafus.html