On September 8, 2021 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, reported that United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a Market Authorisation Application (MAA) seeking the approval of tebentafusp (IMCgp100) for the treatment of patients with metastatic uveal melanoma (mUM) (Press release, Immunocore, SEP 8, 2021, View Source [SID1234587420]).
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Tebentafusp is also being reviewed in the UK under the U.S. Food and Drug Administration’s (FDA) Project Orbis initiative, which enables concurrent review by the health authorities in participating partner countries. As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp. In the United States, the BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program.
The regulatory submissions for tebentafusp are based on data from the randomized Phase 3 IMCgp100-202 clinical trial evaluating tebentafusp in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be frequently insensitive to other immunotherapies. In the final study analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 [95% CI (0.37, 0.71); p< 0.0001] over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).
Bahija Jallal, Chief Executive Officer of Immunocore, said: "We are delighted that the MHRA has accepted our application for tebentafusp and the FDA has selected tebentafusp for the Project Orbis initiative. As a UK-founded biotech company pioneering the field of TCR therapeutics, we are encouraged with these regulatory milestones that brings us closer to helping people with metastatic uveal melanoma in the UK and abroad. The regulatory agencies recognise the urgent need for an approved treatment specific to mUM, an aggressive form of cancer for which the recommended option for patients is enrolment into a clinical trial."