Immunocore announces FDA approval of KIMMTRAK®(tebentafusp-tebn)for the treatment of unresectable or metastatic uveal melanoma

KIMMTRAKis the firstand onlyFDA approved therapy for the treatment of unresectable or metastatic uveal melanoma(mUM)

KIMMTRAK is the first T cell receptor(TCR) therapeuticto receive regulatory approval

KIMMTRAK demonstrated statistically and clinically meaningful overall survival(OS)benefit, hazard ratio of 0.51, with median OS of almost 22 months Company to host an investor call today at8:30 AMET

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, Wednesday, January 26, 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-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, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

KIMMTRAK’s approval establishes many firsts as the first TCR therapeutic to receive regulatory approval from the FDA, the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

Bahija Jallal, Chief Executive Officer of Immunocore, said:“Today’s approval of KIMMTRAKis a historic milestone and the culmination of years of dedicationby the Immunocore team, patients,and our healthcare partners. Every year in the United States, hundreds of people are diagnosed withmetastaticuveal melanoma who, until now, hadno approved treatment options. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and weare focused on making KIMMTRAKavailable as quickly as possible.

Dr. Jallal continues, “We’re also proud to have developedthe world’s first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explorefurther breakthroughdiscoveries in TCR therapeutics for the treatment of other cancersand diseases with high unmet need.”

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood, MD,director of the Melanoma Center at the UPMC Hillman Cancer Center. “The approval of KIMMTRAK(tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offershope to those with this aggressive form of cancer.”

The approval of KIMMTRAK is based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. The randomized pivotal trial evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized in a 2:1 ratio to either KIMMTRAK or investigator’s choice. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p<0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the clinical trials, across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity.

“When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no treatment options shown to extend life.” said Sara Selig, MD, MPH, Co-Founder and Director of the Melanoma Research Foundation’s(MRF)CURE OM initiative.“Now, for the first time in the history of this disease, we will soon seeextended survival in the nextgeneration of metastatic uveal melanoma patients.”

In the randomized Phase 3 trial of KIMMTRAK (tebentafusp-tebn), treatment-related adverse reactions were manageable and consistent with the proposed mechanism. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse reactions were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in