PRESS RELEASE
European CommissionApproves KIMMTRAK®(tebentafusp)for the treatment of unresectable or metastatic uveal melanoma
KIMMTRAK is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma
KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 4 April 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 European Commission (EC) has approved KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.
“The approval of KIMMTRAK by the European Commissionis ahistoric step as the first ever TCR therapy to be approved in the E.U.,” said Bahija Jallal, Chief Executive Officer of Immunocore. “KIMMTRAK, abispecific T-cell engager,is the firsttherapy to demonstrate a survival benefit in patients with unresectable or metastatic uveal melanoma. We are excited about what today’s approval means for patients and their caregivers and we are working closely with national health authorities to make KIMMTRAK available as quickly as possible.”The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in February 2022. 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. 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 favoured KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p<0.0001, over investigator’s choice of treatment (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In this study IMCgp100-202, 43% of patients received treatment beyond progression with tebentafusp with no new safety signals identified. Median duration of tebentafusp treatment beyond progression was 8 weeks. Of the total tebentafusp infusions during the study, 21.5% was administered after progression. “For years, metastatic uveal melanoma patients have had no treatment choice that is active– today’s approval offers them new hope and a chance at longer survival,” commented Dr.Sophie Piperno-Neumann, Medical Oncologist at the Institute Curie.“As a treating physician, it is heart-warming to finally be able to offer a licensed medicine to eligible patients. KIMMTRAK represents a paradigm shift in the treatment of unresectable or metastatic uveal melanoma.”
In the randomised Phase 3 trial of KIMMTRAK (tebentafusp), treatment-related adverse reactions were generally 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