Tebentafusp in Metastatic Uveal Melanoma: A Meta-analysis.
[BACKGROUND] Tebentafusp is the first systemic therapy to improve survival outcomes for patients with HLA-A*02:01-positive metastatic uveal melanoma (mUM).
- 95% CI 19.2-23.1
- 연구 설계 meta-analysis
APA
Saldanha EF, Noronha MM, et al. (2026). Tebentafusp in Metastatic Uveal Melanoma: A Meta-analysis.. Targeted oncology, 21(1), 37-47. https://doi.org/10.1007/s11523-025-01187-9
MLA
Saldanha EF, et al.. "Tebentafusp in Metastatic Uveal Melanoma: A Meta-analysis.." Targeted oncology, vol. 21, no. 1, 2026, pp. 37-47.
PMID
41335285
Abstract
[BACKGROUND] Tebentafusp is the first systemic therapy to improve survival outcomes for patients with HLA-A*02:01-positive metastatic uveal melanoma (mUM). However, outside the pivotal study, limited data for tebentafusp are reported in literature.
[OBJECTIVE] To evaluate the efficacy and safety of tebentafusp in patients with human leukocyte antigen (HLA)-A*02:01-positive mUM across cohort studies and clinical trials.
[PATIENTS AND METHODS] PubMed, EMBASE, Cochrane, and Web of Science (up to July 2025) were surveyed for studies evaluating tebentafusp in patients with HLA-A*02:01-positive mUM. A meta-analysis using a random-effects model and the inverse variance method was conducted; Kaplan-Meier curves, where available, were used to recreate the time-to-event data. The primary objective was efficacy, including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). The secondary objective was to evaluate all-grade and severe (grade ≥ 3 or higher) adverse events (AEs).
[RESULTS] A total of 997 patients from 12 cohorts were included. Using reconstructed time-to-event outcomes from published Kaplan-Meier curves, the estimated median PFS was 3.9 months (95% confidence interval [CI] 3.77-4.92). The median OS was 21.2 months (95% CI 19.2-23.1). When stratified by study design, the median OS was similar between prospective and retrospective studies: 21.2 months (95% CI 19.2-23.8) and 21.1 months (95% CI 18.1-33.6), respectively. Likewise, median progression-free survival (PFS) was comparable between prospective and retrospective studies: 3.8 months (95% CI 3.25-5.5) and 3.9 months (95% CI 3.8-4.9), respectively. The rate of cytokine- and cutaneous-mediated events was 67% (95% CI 45-84; I = 94.4%) and 64% (95% CI 28-89; I = 97.3%), respectively. Severe AEs for cytokine-mediated events were 3% (95% CI 1-13; I = 87.6%), and cutaneous-mediated events were 11% (95% CI 8-14; I = 0%). The discontinuation rate was 2% (95% CI 1-4; I = 0%).
[CONCLUSIONS] Tebentafusp for patients with HLA-A*02:01-positive mUM is associated with improved survival outcomes and manageable toxicity. These findings support tebentafusp as the standard of care for this patient population.
[OBJECTIVE] To evaluate the efficacy and safety of tebentafusp in patients with human leukocyte antigen (HLA)-A*02:01-positive mUM across cohort studies and clinical trials.
[PATIENTS AND METHODS] PubMed, EMBASE, Cochrane, and Web of Science (up to July 2025) were surveyed for studies evaluating tebentafusp in patients with HLA-A*02:01-positive mUM. A meta-analysis using a random-effects model and the inverse variance method was conducted; Kaplan-Meier curves, where available, were used to recreate the time-to-event data. The primary objective was efficacy, including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). The secondary objective was to evaluate all-grade and severe (grade ≥ 3 or higher) adverse events (AEs).
[RESULTS] A total of 997 patients from 12 cohorts were included. Using reconstructed time-to-event outcomes from published Kaplan-Meier curves, the estimated median PFS was 3.9 months (95% confidence interval [CI] 3.77-4.92). The median OS was 21.2 months (95% CI 19.2-23.1). When stratified by study design, the median OS was similar between prospective and retrospective studies: 21.2 months (95% CI 19.2-23.8) and 21.1 months (95% CI 18.1-33.6), respectively. Likewise, median progression-free survival (PFS) was comparable between prospective and retrospective studies: 3.8 months (95% CI 3.25-5.5) and 3.9 months (95% CI 3.8-4.9), respectively. The rate of cytokine- and cutaneous-mediated events was 67% (95% CI 45-84; I = 94.4%) and 64% (95% CI 28-89; I = 97.3%), respectively. Severe AEs for cytokine-mediated events were 3% (95% CI 1-13; I = 87.6%), and cutaneous-mediated events were 11% (95% CI 8-14; I = 0%). The discontinuation rate was 2% (95% CI 1-4; I = 0%).
[CONCLUSIONS] Tebentafusp for patients with HLA-A*02:01-positive mUM is associated with improved survival outcomes and manageable toxicity. These findings support tebentafusp as the standard of care for this patient population.
MeSH Terms
Humans; Melanoma; Uveal Neoplasms; Uveal Melanoma; Neoplasm Metastasis