Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma.[7][10] Participants were required to be HLA-A*02:01 genotype positive identified by a central assay.[7] Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered.[7] Prior surgical resection of oligometastatic disease was permitted.[7] Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded.[7] Two thirds of the participants were treated with tebentafusp and one third of the participants were treated with comparator drugs based on investigators' choice that included pembrolizumab, ipilimumab, or dacarbazine.[10] The benefit of tebentafusp was evaluated by measuring how long participants lived after starting treatment with tebentafusp compared with participants who received comparator drugs.[10] The trial was conducted at 58 sites across 14 countries including Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Poland, the Russian Federation, Spain, Switzerland, Ukraine, the United Kingdom, and the United States.[10] This same clinical trial was used to assess efficacy and safety.[10]
On 24 February 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kimmtrak, intended for the treatment of uveal melanoma.[13][14] The applicant for this medicinal product is Immunocore Ireland Limited.[13][14] Tebentafusp was approved for medical use in the European Union in April 2022.[8][15]
^ ab"Kimmtrak EPAR". European Medicines Agency (EMA). 24 January 2022. Archived from the original on 22 April 2022. Retrieved 22 April 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
^ ab"Kimmtrak: Pending EC decision". European Medicines Agency. 24 February 2022. Archived from the original on 26 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.