Tebentafusp Explained

Tradename:Kimmtrak
Dailymedid:Tebentafusp
Pregnancy Au:C
Routes Of Administration:Intravenous
Atc Prefix:L01
Atc Suffix:XX75
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:/Schedule D[3]
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Cas Number:1874157-95-5
Drugbank:DB15283
Unii:N658GY6L3E
Kegg:D12296
Synonyms:IMCgp100, tebentafusp-tebn

Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer).[6] [7] Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager. Tebentafusp is given by intravenous infusion.

The most common side effects include cytokine release syndrome, rash, pyrexia (fever), pruritus (itching), fatigue (tiredness), nausea, chills, abdominal pain (stomach pain), edema (swelling), hypotension (low blood pressure), dry skin, headache, and vomiting, and abnormal liver blood tests.

Tebentafusp was approved for medical use in the United States in January 2022.[8] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9] [10]

Medical uses

Tebentafusp is indicated for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

History

Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma. Participants were required to be HLA-A*02:01 genotype positive identified by a central assay. Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered. Prior surgical resection of oligometastatic disease was permitted. Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded. 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. The benefit of tebentafusp was evaluated by measuring how long participants lived after starting treatment with tebentafusp compared with participants who received comparator drugs. 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. This same clinical trial was used to assess efficacy and safety.

The U.S. Food and Drug Administration (FDA) granted Immunocore's application for tebentafusp priority review, breakthrough therapy, and orphan drug designations.

Society and culture

Legal status

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. The applicant for this medicinal product is Immunocore Ireland Limited.[11] [12] Tebentafusp was approved for medical use in the European Union in April 2022.[13] [14]

Notes and References

  1. Web site: Kimmtrak APMDS . Therapeutic Goods Administration (TGA) . 15 June 2022 . 18 June 2022 . 18 June 2022 . https://web.archive.org/web/20220618051806/https://www.tga.gov.au/apm-summary/kimmtrak . live .
  2. Web site: Therapeutic Goods (Poisons Standard—June 2024) Instrument 2024 . Federal Register of Legislation . 30 May 2024 . 10 June 2024.
  3. Web site: Kimmtrak Product information . Health Canada . 25 April 2012 . 30 September 2022 . 1 October 2022 . https://web.archive.org/web/20221001061042/https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=101664 . live .
  4. Web site: Kimmtrak (tebentafusp) 200 micrograms/ mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC) . (emc) . 4 July 2022 . 17 June 2023 . 10 March 2024 . https://web.archive.org/web/20240310064620/https://www.medicines.org.uk/emc/product/13842/smpc . live .
  5. Web site: Kimmtrak- tebentafusp injection, solution, concentrate . DailyMed . 26 January 2022 . 20 February 2022 . 21 February 2022 . https://web.archive.org/web/20220221055329/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 . live .
  6. Web site: FDA approves tebentafusp-tebn for unresectable . U.S. Food and Drug Administration (FDA) . 25 January 2022 . 28 January 2022 . 27 January 2022 . https://web.archive.org/web/20220127192110/https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma . live .
  7. Damato BE, Dukes J, Goodall H, Carvajal RD . Tebentafusp: T Cell Redirection for the Treatment of Metastatic Uveal Melanoma . Cancers . 11 . 7 . July 2019 . 971 . 31336704 . 6679206 . 10.3390/cancers11070971 . free .
  8. Web site: Drug Trials Snapshots: Kimmtrak . U.S. Food and Drug Administration (FDA) . 15 June 2023 . 17 June 2023 . 10 March 2024 . https://web.archive.org/web/20240310064436/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak . live .
  9. Web site: Advancing Health Through Innovation: New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . 10 January 2023 . 22 January 2023 . 21 January 2023 . https://web.archive.org/web/20230121035714/https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 . live .
  10. New Drug Therapy Approvals 2022 . U.S. Food and Drug Administration (FDA) . January 2024 . PDF . 14 January 2024 . https://web.archive.org/web/20240114065648/https://www.fda.gov/media/164429/download . 14 January 2024 . live .
  11. Web site: Kimmtrak: Pending EC decision . European Medicines Agency . 24 February 2022 . 27 February 2022 . 26 February 2022 . https://web.archive.org/web/20220226231548/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kimmtrak . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  12. New medicine for rare type of eye cancer . European Medicines Agency (EMA) . 25 February 2022 . 27 February 2022 . 27 February 2022 . https://web.archive.org/web/20220227042338/https://www.ema.europa.eu/en/news/new-medicine-rare-type-eye-cancer . live .
  13. Web site: Kimmtrak EPAR . European Medicines Agency (EMA) . 24 January 2022 . 22 April 2022 . 22 April 2022 . https://web.archive.org/web/20220422165803/https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  14. Web site: Kimmtrak Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304085036/https://ec.europa.eu/health/documents/community-register/html/h1630.htm . live .

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