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  • 12 April 2021
    Immunocore presents phase 3 data comparing tebentafusp with investigator’s choice in the clinical trial plenary session at the American Association for Cancer Research 2021 Annual Meeting

    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, presented data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) in the clinical trial plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021.

    Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM.  The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism. 

    “This is the first investigational therapy to demonstrate improved OS in metastatic uveal melanoma,” said Bahija Jallal, Chief Executive Officer of Immunocore. “We believe these data demonstrate that tebentafusp has the potential to provide a meaningful difference in the treatment of metastatic uveal melanoma, a highly aggressive disease for which there is no effective standard of care.” 

    In a separate oral presentation on Monday April 12, Marcus O. Butler shared an analysis of previously treated uveal melanoma patients who had prolonged survival. 

    Two posters from the phase 2 IMCgp100-102 study are also available for on-demand viewing at the AACR website.  These analyses investigated the proposed mechanism of action (MoA), including inducing an increase in cytokines and T cell trafficking into the tumor. 

    Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021. 

    The Company will host a conference call for industry, health and investment professionals on Tuesday, April 13th at 7:30 am ET to discuss the phase 3 IMCgp100-202 trial. The webcast can be accessed directly through this link. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Investor Relations section of the Company’s website for at least 90 days.