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Tebentafusp
Pharmaceutical drug

Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer). 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. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.

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Medical uses

Tebentafusp is indicated for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.15161718

History

Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma.1920 Participants were required to be HLA-A*02:01 genotype positive identified by a central assay.21 Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered.22 Prior surgical resection of oligometastatic disease was permitted.23 Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded.24 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.25 The benefit of tebentafusp was evaluated by measuring how long participants lived after starting treatment with tebentafusp compared with participants who received comparator drugs.26 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.27 This same clinical trial was used to assess efficacy and safety.28

The U.S. Food and Drug Administration (FDA) granted Immunocore's application for tebentafusp priority review, breakthrough therapy, and orphan drug designations.29

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.3031 The applicant for this medicinal product is Immunocore Ireland Limited.3233 Tebentafusp was approved for medical use in the European Union in April 2022.3435

  • Clinical trial number NCT03070392 for "Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma" at ClinicalTrials.gov

References

  1. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  2. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  3. Damato BE, Dukes J, Goodall H, Carvajal RD (July 2019). "Tebentafusp: T Cell Redirection for the Treatment of Metastatic Uveal Melanoma". Cancers. 11 (7): 971. doi:10.3390/cancers11070971. PMC 6679206. PMID 31336704. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679206 ↩

  4. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  5. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  6. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  7. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  8. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  9. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  10. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  11. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  12. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  13. "Advancing Health Through Innovation: New Drug Therapy Approvals 2022". U.S. Food and Drug Administration (FDA). 10 January 2023. Archived from the original on 21 January 2023. Retrieved 22 January 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2022 ↩

  14. New Drug Therapy Approvals 2022 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 14 January 2024. Retrieved 14 January 2024. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/media/164429/download ↩

  15. "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24a49f57-d2fc-4ffe-9eb1-fe0460c6b067 ↩

  16. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  17. Damato BE, Dukes J, Goodall H, Carvajal RD (July 2019). "Tebentafusp: T Cell Redirection for the Treatment of Metastatic Uveal Melanoma". Cancers. 11 (7): 971. doi:10.3390/cancers11070971. PMC 6679206. PMID 31336704. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6679206 ↩

  18. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  19. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  20. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  21. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  22. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  23. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  24. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  25. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  26. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  27. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  28. "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Archived from the original on 10 March 2024. Retrieved 17 June 2023. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-kimmtrak ↩

  29. "FDA approves tebentafusp-tebn for unresectable". U.S. Food and Drug Administration (FDA). 25 January 2022. Archived from the original on 27 January 2022. Retrieved 28 January 2022. This article incorporates text from this source, which is in the public domain. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma ↩

  30. "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. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kimmtrak ↩

  31. "New medicine for rare type of eye cancer". European Medicines Agency (EMA) (Press release). 25 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. https://www.ema.europa.eu/en/news/new-medicine-rare-type-eye-cancer ↩

  32. "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. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/kimmtrak ↩

  33. "New medicine for rare type of eye cancer". European Medicines Agency (EMA) (Press release). 25 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. https://www.ema.europa.eu/en/news/new-medicine-rare-type-eye-cancer ↩

  34. "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. https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak ↩

  35. "Kimmtrak Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023. https://ec.europa.eu/health/documents/community-register/html/h1630.htm ↩