Drug updated on 4/18/2024
| Dosage Form | Injection (subcutaneous; 100 mcg/0.5 mL in a single-dose vial) |
| Drug Class | Bispecific gp100 peptide-HLA-directed CD3 T cell engagers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Summary
- Tebentafusp-tebn (Kimmtrak) is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
- The information was derived from a single systematic review/meta-analysis that provided comprehensive data comparing Kimmtrak's effectiveness and safety to other drugs used in treating this condition.
- In terms of overall survival, tebentafusp-tebn outperformed combined immune checkpoint blockade (ICB), anti-PD-(L)1 antibody, chemotherapy, targeted therapies, and anti-CTLA-4 antibody treatments. It showed a median overall survival rate of 22.4 months compared to the next best option, combined ICB at 15.7 months.
- However, progression-free survival rates were similar across all treatment groups, ranging from 2.7 to 3.4 months, indicating no significant advantage for any particular drug, including tebentafusp-tebn, in delaying disease progression.
- The study specifically addressed patients with advanced stages of uveal melanoma but did not provide detailed subgroup considerations within this population type.
- Safety profiles were not explicitly mentioned in the study reviewed; however, hazard ratios suggested that tebentafusp-tebn has a favorable profile, reducing the risk of death when compared against other treatments such as combined ICB using different statistical models like MAIC, 2SMAIC, and STC.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Kimmtrak (tebentafusp-tebn) Prescribing Information. | 2022 | Immunocore Limited, Abingdon, United Kingdom |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Is tebentafusp superior to combined immune checkpoint blockade and other systemic treatments in metastatic uveal melanoma? A comparative efficacy analysis with population adjustment. | 2023 | Cancer Treatment Reviews |
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 |