NEW YORK – Immunocore said on Friday that it plans to submit a biologic license application to the US Food and Drug Administration in Q3 2021 for tebentafusp to treat HLA-A*02:01-positive patients with metastatic uveal melanoma.
In interim data from a Phase III trial of tebentafusp in melanoma, researchers found the treatment improved overall survival as a first-line monotherapy compared to investigator’s choice of either chemotherapy, ipilimumab (Bristol Myers Squibb's Yervoy), or pembrolizumab (Merck's Keytruda). That survival data was not mature, but estimates suggested patients taking tebentafusp had a one-year overall survival rate of approximately 73 percent compared to 58 percent for the investigator's choice drugs. To be eligible for the Phase III study, patients needed to be positive by central assay for HLA-A*02:01, an allele where gp100, a melanoma-associated antigen targeted by tebentafusp, is presented.
An earlier Phase I/II study of tebentafusp in melanoma found that HLA-A*02:01-positive patients taking tebentafusp had a one-year overall survival rate of 65 percent, similar to the estimates in the Phase III trial.
The company also said on Friday that tebentafusp was granted breakthrough therapy designation by the FDA for this indication.
"We are delighted that the FDA has granted breakthrough therapy designation for tebentafusp based on the survival benefit from our Phase III clinical trial announced in November 2020," Immunocore CEO Bahija Jallal said in a statement. "There is an urgent need for an approved treatment for this rare and aggressive form of melanoma, and we look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible."
Tebentafusp was the first product developed using Immunocore's T-cell receptor technology platform, ImmTAX, which activates T cells to target and kill tumor cells. The drug is a bispecific fusion protein that redirects T cells to kill tumor cells expressing gp100.
The FDA had previously granted fast track and orphan drug designation for tebentafusp to treat uveal melanoma. UK regulators also designated the drug a promising innovative medicine under the UK Early Access to Medicines Scheme.