Medical Information

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 25 February 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 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
The CHMP positive opinion is one of the final steps before marketing authorization is granted by the EMA, which has the authority to approve medicines for use throughout the European Union. If approved, KIMMTRAK® would be the first T cell receptor therapy commercially available in Europe. Immunocore’s Marketing Authorisation Application was reviewed under EMA’s accelerated assessment procedure, which is given if the CHMP determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.

“The CHMP’s recommendation of KIMMTRAK brings us closer to providing a much-needed treatment option to patients in Europe,” said Bahija Jallal, Chief Executive Officer of Immunocore. “This year, hundreds of people across the EU will be diagnosed with metastatic uveal melanoma. Left with minimal-to-no options, these patients have a devastating prognosis. KIMMTRAK is the first therapy to demonstrate a survival benefit in patients with this disease, providing new hope to these individuals and to the doctors treating them.”
The recommendation comes just one month after regulatory approval of KIMMTRAK by the United States Food and Drug Administration (FDA) last month (January 25), making it the first and now only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.
The CHMP recommendation 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.1
Dr. Paul Nathan, uveal melanoma lead for the European Organisation for Research and Treatment of Cancer, said: “Metastatic uveal melanoma has historically been associated with a particularly poor prognosis and, up until now, has been refractory to most treatments. KIMMTRAK represents a significant new form of treatment, offering the chance at a longer life for patients with the disease, and with it, hope.”
In the randomised Phase 3 trial of KIMMTRAK (tebentafusp), treatment-related adverse reactions were manageable and consistent with the proposed mechanism of action. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse events were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in <1% of patients and were generally well-managed. There were no Grade 4 CRS events observed in the Phase 3 clinical trial.
The United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have each accepted the submission of the Company’s Marketing Authorisation Application. In April of 2021, Immunocore launched a global early access program to make KIMMTRAK readily available to mUM patients. The Company is focused on continuing to treat these patients with KIMMTRAK as regulatory approval is sought in the EU and the individual EU Member States. There are currently over 200 patients in the early access program.