KIMMTRAK is approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma.
Immunocore Holdings announce 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 Commission is a historic step as the first ever TCR therapy to be approved in the E.U.," said Bahija Jallal, chief executive officer of Immunocore. "KIMMTRAK, a bispecific T-cell engager, is the first therapy 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, 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 <1% of patients and were generally well-managed. There were no Grade 4 or higher CRS events observed in the Phase 3 clinical trial.
Dr. Jessica Hassel, head of dermato-oncology at Heidelberg University Hospital, said "The approval of tebentafusp by the EMA is a great step forward in the treatment of metastatic uveal melanoma. Being the first agent with a proven survival benefit, this approval provides hope to patients with uveal melanoma. And for us treating physicians, it is a significant advancement to be able to offer these patients an effective treatment with good tolerability."
With EC approval, KIMMTRAK has received marketing authorisation in all E.U. member states, and following completion of related national procedures, also in Iceland, Liechtenstein, and Norway. 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 January 2022, the United States Food and Drug Administration (FDA) approved KIMMTRAK for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).