Immunocore’s tebentafusp granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma from FDA

Excerpt from the Press Release:

OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) — Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Bahija Jallal, Chief Executive Officer of Immunocore, said: “We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020. 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.”

In an initial pre-planned interim analysis of a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, tebentafusp demonstrated superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

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