Tebentafusp

Last updated

Tebentafusp
Clinical data
Trade names Kimmtrak
Other namesIMCgp100, tebentafusp-tebn
License data
Pregnancy
category
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Tebentafusp, sold under the brand name Kimmtrak, is an anti-cancer medication used to treat uveal melanoma (eye cancer). [5] [6] [8] Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager. [5] [6] Tebentafusp is given by intravenous infusion. [5]

Contents

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. [5] [6] [9]

Tebentafusp was approved for medical use in the United States in January 2022. [5] [6] [9] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [10]

Medical uses

Tebentafusp is indicated for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. [5] [6] [8] [9]

History

Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma. [6] [9] Participants were required to be HLA-A*02:01 genotype positive identified by a central assay. [6] Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered. [6] Prior surgical resection of oligometastatic disease was permitted. [6] Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded. [6] 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. [9] The benefit of tebentafusp was evaluated by measuring how long participants lived after starting treatment with tebentafusp compared with participants who received comparator drugs. [9] 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. [9] This same clinical trial was used to assess efficacy and safety. [9]

The U.S. Food and Drug Administration (FDA) granted Immunocore's application for tebentafusp priority review, breakthrough therapy, and orphan drug designations. [6]

Society and culture

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. [11] [12] 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. [7] [13]

Related Research Articles

<span class="mw-page-title-main">Melphalan</span> Chemical compound

Melphalan, sold under the brand name Alkeran among others, is a chemotherapy medication used to treat multiple myeloma; malignant lymphoma; lymphoblastic and myeloblastic leukemia; childhood neuroblastoma; ovarian cancer; mammary adenocarcinoma; and uveal melanoma. It is taken by mouth or by injection into a vein.

<span class="mw-page-title-main">Tremelimumab</span>

Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma. Tremelimumab is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system.

<span class="mw-page-title-main">Bi-specific T-cell engager</span>

Bi-specific T-cell engagers (BiTEs) are a class of artificial bispecific monoclonal antibodies that are investigated for use as anti-cancer drugs. They direct a host's immune system, more specifically the T cells' cytotoxic activity, against cancer cells. BiTE is a registered trademark of Micromet AG.

<span class="mw-page-title-main">Nivolumab</span> Cancer drug

Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer. This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction (GEJ) cancer. It is used by slow injection into a vein.

<span class="mw-page-title-main">Trametinib</span> Anticancer medication

Trametinib, sold under the brand name Mekinist among others, is an anticancer medication used for the treatment of melanoma. It is a MEK inhibitor drug with anti-cancer activity. It inhibits MEK1 and MEK2. It is taken by mouth.

<span class="mw-page-title-main">Dabrafenib</span> Chemical compound

Dabrafenib, sold under the brand name Tafinlar among others, is an anti-cancer medication used for the treatment of cancers associated with a mutated version of the gene BRAF. Dabrafenib acts as an inhibitor of the associated enzyme B-Raf, which plays a role in the regulation of cell growth.

<span class="mw-page-title-main">Pembrolizumab</span> Pharmaceutical drug used in cancer treatment

Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is administered by slow intravenous injection.

<span class="mw-page-title-main">Binimetinib</span> Chemical compound

Binimetinib, sold under the brand name Mektovi, is an anti-cancer medication used to treat various cancers. Binimetinib is a selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway. Inappropriate activation of the pathway has been shown to occur in many cancers. In June 2018 it was approved by the FDA in combination with encorafenib for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma. In October 2023, it was approved by the FDA for treatment of NSCLC with a BRAF V600E mutation in combination with encorafenib. It was developed by Array Biopharma.

<span class="mw-page-title-main">Sacituzumab govitecan</span> Antibody-drug conjugate

Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.

<span class="mw-page-title-main">Capmatinib</span> Chemical compound

Capmatinib, sold under the brand name Tabrecta, is an anticancer medication used for the treatment of metastatic non-small cell lung cancer whose tumors have a mutation that leads to the exon 14 skipping of the MET gene, which codes for the membrane receptor HGFR.

<span class="mw-page-title-main">Tucatinib</span> Chemical compound

Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics.

Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.

Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD). It is given by intravenous infusion. Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.

<span class="mw-page-title-main">Trastuzumab deruxtecan</span> Medication

Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan. It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma. Trastuzumab binds to and blocks signaling through epidermal growth factor receptor 2 (HER2/neu) on cancers that rely on it for growth. Additionally, once bound to HER2 receptors, the antibody is internalized by the cell, carrying the bound deruxtecan along with it, where it interferes with the cell's ability to make DNA structural changes and replicate its DNA during cell division, leading to DNA damage when the cell attempts to replicate itself, destroying the cell.

<span class="mw-page-title-main">Avapritinib</span> Chemical compound

Avapritinib, sold under the brand name Ayvakit among others, is a medication used for the treatment of advanced systemic mastocytosis and for the treatment of tumors due to one specific rare mutation: it is specifically intended for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbor a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. Avapritinib is a kinase inhibitor.

<span class="mw-page-title-main">Pemigatinib</span> Pharmaceutical drug

Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading.

<span class="mw-page-title-main">Selpercatinib</span> Chemical compound

Selpercatinib, sold under the brand name Retevmo among others, is a medication for the treatment of cancers in people whose tumors have an alteration in a specific gene. It is taken by mouth.

Pralsetinib, sold under the brand name Gavreto, is a medication approved for RET mutation-positive medullary thyroid cancer (MTC) and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy. Pralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.

<span class="mw-page-title-main">Adagrasib</span> Medication

Adagrasib, sold under the brand name Krazati, is an anticancer medication used to treat non-small cell lung cancer. Adagrasib is an inhibitor of the RAS GTPase family. It is taken by mouth. It is being developed by Mirati Therapeutics.

Nivolumab/relatlimab, sold under the brand name Opdualag, is a fixed-dose combination medication use to treat melanoma. It contains nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody. It is given by intravenous infusion.

References

  1. 1 2 "Kimmtrak APMDS". Therapeutic Goods Administration (TGA). 15 June 2022. Archived from the original on 18 June 2022. Retrieved 18 June 2022.
  2. ↑ "Kimmtrak Product information". Health Canada. 25 April 2012. Archived from the original on 1 October 2022. Retrieved 30 September 2022.
  3. ↑ "Kimmtrak (tebentafusp) 200 micrograms/ mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 4 July 2022. Retrieved 17 June 2023.
  4. ↑ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA . Retrieved 22 October 2023.
  5. 1 2 3 4 5 6 7 "Kimmtrak- tebentafusp injection, solution, concentrate". DailyMed. 26 January 2022. Archived from the original on 21 February 2022. Retrieved 20 February 2022.
  6. 1 2 3 4 5 6 7 8 9 10 11 12 "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. 1 2 "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.
  8. 1 2 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.
  9. 1 2 3 4 5 6 7 8 "Drug Trials Snapshots: Kimmtrak". U.S. Food and Drug Administration (FDA). 15 June 2023. Retrieved 17 June 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  10. ↑ "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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. 1 2 "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.
  12. 1 2 "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.
  13. ↑ "Kimmtrak Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.