Clinical outcomes of tebentafusp in metastatic uveal melanoma: a systematic review and single-arm meta-analysis - Report - MDSpire

Clinical outcomes of tebentafusp in metastatic uveal melanoma: a systematic review and single-arm meta-analysis

  • By

  • Han Cai

  • Zhilong Huang

  • Bing-Long Wang

  • Ming Wei

  • Miao Tian

  • Hongmei Zheng

  • June 17, 2026

  • 0 min

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Clinical Report: Efficacy and Safety of Tebentafusp in Metastatic Uveal Melanoma

Overview

This systematic review and meta-analysis evaluates the efficacy and safety of tebentafusp in patients with metastatic uveal melanoma, revealing a median overall survival of 21.3 months and a median progression-free survival of 3.6 months. Although the treatment shows modest survival benefits, it is associated with a high incidence of adverse events.

Background

Uveal melanoma is the most common primary intraocular malignancy in adults, with a significant risk of metastasis leading to poor prognosis. Traditional treatments have limited efficacy, highlighting the need for effective systemic therapies. Tebentafusp has emerged as a promising treatment option for HLA-A*02:01-positive patients with metastatic uveal melanoma.

Data Highlights

OutcomeRate95% CI
Median Overall Survival (OS)21.3 months-
Median Progression-Free Survival (PFS)3.6 months-
Partial Response (PR)0.09(0.05 to 0.14)
Stable Disease (SD)0.39(0.35 to 0.43)
Progressive Disease (PD)0.79(0.32 to 0.97)
Objective Response Rate (ORR)0.09(0.06 to 0.13)
Disease Control Rate (DCR)0.27(0.20 to 0.36)
Any Grade Cytokine Release Syndrome (CRS)0.88(0.84 to 0.91)
Any Grade Treatment-Related Adverse Events (trAEs)0.98(0.75 to 1.00)

Key Findings

  • The median overall survival for patients treated with tebentafusp was 21.3 months.
  • The median progression-free survival was reported at 3.6 months.
  • Partial response rate was 9%, with stable disease observed in 39% of patients.
  • Adverse events were common, with any grade cytokine release syndrome occurring in 88% of patients.
  • Most frequent adverse reactions included pyrexia (83%), nausea (58%), and fatigue (54%).

Clinical Implications

Tebentafusp represents a significant advancement in the treatment of metastatic uveal melanoma, particularly for HLA-A*02:01-positive patients. Clinicians should be aware of the potential for manageable adverse events, including cytokine release syndrome, when considering this therapy.

Conclusion

Tebentafusp offers a modest survival benefit for patients with metastatic uveal melanoma, despite low response rates. Further research is needed to confirm these findings and optimize treatment strategies.

Related Resources & Content

  1. Funchain, P., Seth, R., ASCO Post, 2022 -- ASCO Guideline Update for Systemic Melanoma Therapy Addresses New Treatment Option for Uveal Melanoma
  2. Nathan, P., et al., NEJM, 2021 -- Overall Survival With the Bispecific Fusion Protein Tebentafusp for Metastatic Uveal Melanoma KEY POINTS
  3. Frontiers in Oncology, 2026 -- Comparative efficacy of therapeutic modalities for metastatic uveal melanoma: a systemic review and network meta-analysis
  4. ESMO, 2026 -- Uveal melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up
  5. NEJM, 2021 -- Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma
  6. The ASCO Post — ASCO Guideline Update for Systemic Melanoma Therapy Addresses New Treatment Option for Uveal Melanoma
  7. KIMMTRAK- tebentafusp injection, solution, concentrate
  8. Uveal melanoma: ESMO–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up - ScienceDirect
  9. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma | New England Journal of Medicine

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