Drug updated on 10/24/2024
| Dosage Form | Injection (subcutaneous; 100 mcg/0.5 mL) |
| Drug Class | Bispecific gp100 peptide-HLA-directed CD3 T cell engagers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- The objective response rate (ORR) for tebentafusp in metastatic uveal melanoma (mUM) patients is 8% (95% Confidence Interval (CI): 0.05-0.12), indicating measurable response in a minority of patients.
- The disease control rate (DCR) is 51% (95% CI: 0.44-0.57), encompassing complete response, partial response, and stable disease in mUM patients.
- The overall incidence of any grade adverse events is 0.99 (95% CI: 0.95-1.00), with 50% of patients experiencing grade 3-4 adverse events (95% CI: 0.41-0.59), and only 1% of patients discontinuing treatment due to adverse events (95% CI: 0-0.03).
- There are no safety comparisons with other drugs, and no specific population types or subgroups are mentioned in the safety data.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Kimmtrak (tebentafusp-tebn) Prescribing Information. | 2022 | Immunocore Commercial LLC., Conshohocken, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of tebentafusp in patients with metastatic uveal melanoma: A systematic review and meta-analysis | 2024 | Human Vaccines & Immunotherapeutics |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp. | 2023 | European Journal of Cancer |