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Therapeutics
Tebentafusp (Kimmtrak)

Tebentafusp (Kimmtrak)

Antineoplastic Agent

Tebentafusp (Kimmtrak) is a bispecific fusion protein approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Patient Selection:
  • Ensure patients are HLA-A*02:01-positive before initiating treatment.
  • Tebentafusp is indicated for previously untreated and previously treated patients.
Dosing and Administration:
  • The recommended dose is 20 mcg on Day 1, 30 mcg on Day 8, 68 mcg on Day 15, and 68 mcg once weekly thereafter.
  • Do not administer as an IV push or bolus.
  • Use an in-line filter (0.2 micron) during administration.
  • Administer by intravenous infusion over 15-20 minutes. Monitor patients during and after infusion for at least 16 hours following the first three infusions and for at least 30 minutes after subsequent infusions.
Premedication:
  • Administer antipyretics, antihistamines, and anti-emetics as prescribed before each infusion.
Monitoring:
  • Cytokine Release Syndrome (CRS): Monitor for CRS, which may be serious or life-threatening. Manage with IV fluids, NSAIDs, corticosteroids, oxygen, and vasopressors as needed.
  • Administer tebentafusp in a healthcare setting capable of managing CRS.
  • Monitor vital signs before, during, and after infusion, especially for the first three infusions.
  • Observe patients for at least 16 hours following the first three infusions.
  • Perform liver function tests prior to and during treatment.
  • Laboratory Abnormalities: Monitor for decreased lymphocyte count, increased creatinine, glucose, AST, ALT, decreased hemoglobin, and phosphate.
Adverse Events Management:
  • Common Adverse Reactions: Rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting.
  • Skin reactions are common and may require topical or systemic treatments.
Patient Education:
  • Inform patients about the risk of CRS and its symptoms (fever, chills, hypotension, tachycardia).
  • Advise patients to report any skin reactions or rashes.
  • Educate patients on the importance of staying hydrated and maintaining good nutrition.
  • Support Program: KIMMTRAK CONNECT offers financial assistance, care coordination, and educational resources for patients and caregivers.
Follow-up Care:
  • Emphasize the importance of regular follow-up appointments and blood tests.
  • Encourage patients to keep a symptom diary to discuss with their healthcare team.
Clinical Trials and Efficacy:
  • Phase 3 Study: The IMCgp100-202 study demonstrated improved overall survival and progression-free survival in patients receiving tebentafusp compared to investigator's choice of therapy.
  • Efficacy: Tebentafusp is the first systemic treatment to show a survival benefit in patients with metastatic uveal melanoma.
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Citations: [1] https://www.ncbi.nlm.nih.gov/books/NBK601810/ [2] https://www.youtube.com/watch?v=ijZDW05VVng [3] https://www.kimmtrakhcp.com [4] https://hhs.iowa.gov/media/396/download [5] https://www.pharmacytimes.com/view/phase-3-study-results-show-tebentafusp-provides-long-term-survival-benefit-in-patients-with-metastatic-uveal-melanoma [6] https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf [7] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma [8] https://www.oncnursingnews.com/view/novel-immune-checkpoint-inhibitors-bispecific-antibodies-become-clinical-mainstays-in-melanoma-nursing [9] https://www.ema.europa.eu/en/documents/product-information/kimmtrak-epar-product-information_en.pdf [10] https://www.kimmtrakconnect.com [11] https://www.youtube.com/watch?v=1ES7vuI9YxI [12] https://www.kimmtrakconnect.com/education/ [13] https://www.aetna.com/cpb/medical/data/1000_1099/1005.html [14] https://reference.medscape.com/drug/kimmtrak-tebentafusp-4000245 [15] https://www.curemelanoma.org/patient-eng/melanoma-treatment/immunotherapy/tebentafusp-kimmtrak [16] https://www.kimmtrakhcp.com/safety/ [17] https://www.medicines.org.uk/emc/rmm/2576/Document
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