The MHRA (UK), TGA (Australia) and Health Canada approve Kimmtrak for the treatment of unresectable or metastatic uveal melanoma.-Immunocore
Immunocore Holdings plc ,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 announces that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), the Therapeutic Goods Administration (TGA) in Australia and Health Canada have granted marketing authorization for Kimmtrak (tebentafusp) for the treatment of HLA-A02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
Kimmtrak, a gp100 and CD3 ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) novel bispecific protein, is the first bispecific T cell engager to receive regulatory approval to treat a solid tumor, and the first and only approved therapy for the treatment of unresectable or metastatic uveal melanoma. Marketing authorization by the MHRA, TGA, and Health Canada follows recent approvals from both the FDA and the European Commission (EC).
Professor Sir John Bell, Immunocore Chairman and the Regius Professor of Medicine at the University of Oxford, said: “Kimmtrak is the culmination of more than two decades of scientific discovery. Its approval in the UK, Australia, and Canada, in addition to the United States and European Union, not only represents another important milestone for Immunocore, but a breakthrough for a wholly new category of treatment and for the patients who may experience life-changing benefits, as a result.”
The approvals in the UK, Australia, and Canada of Kimmtrak are based on the results of Immunocore’s Phase III 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 III 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.
Uveal melanoma is an aggressive form of melanoma which affects the eye, with a poor prognosis and no standard of care. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 4,000 new patients diagnosed globally each year (1,500 cases/year in US). Up to 50% of people with uveal melanoma will eventually develop metastatic disease.When the cancer spreads beyond the eye, only approximately 40% of patients will survive for one year.
See- "Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma"-Paul Nathan, M.D., Ph.D., Jessica C. Hassel, M.D., Piotr Rutkowski, M.D., Ph.D., , et al.,for the IMCgp100-202 Investigators. September 23, 2021. Engl J Med 2021; 385:1196-1206. DOI: 10.1056/NEJMoa2103485,.
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