Drug updated on 9/4/2024
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.
Latest News
Summary
- Kimmtrak (tebentafusp-tebn) is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Tebentafusp demonstrated a median overall survival (mOS) of 22.4 months (95% CI: 19.9-29.6), which is superior to combined immune checkpoint blockade (mOS: 15.7 months, 95% CI: 14.4-17.9), anti-PD-(L)1 antibody (mOS: 10.9 months, 95% CI: 9.8-13.4), chemotherapy (mOS: 9.95 months, 95% CI: 8.9-11.2), targeted therapies (mOS: 8.86 months, 95% CI: 7.5-10.8), and anti-CTLA-4 antibody (mOS: 7.8 months, 95% CI: 6.8-9.3).
- Median progression-free survival (mPFS) across all treatment groups, including Tebentafusp, ranged from 2.7 to 3.4 months, indicating no significant differences in mPFS between treatments.
- Tebentafusp showed a comparative hazard ratio (HR) for overall survival (OS) of 0.641 (95% CI: 0.449-0.915) in an unadjusted model versus combined ICB, with lower HRs in population-adjusted models: MAIC HR of 0.386 (95% CI: 0.236-0.631), 2SMAIC HR of 0.378 (95% CI: 0.234-0.612), and STC HR of 0.284 (95% CI: 0.184-0.440).
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |