# Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma

Source: https://onco.cc/key-papers/paper-imcgp100-202-n-engl-j-med-2021/  
OnCo record `paper-imcgp100-202-n-engl-j-med-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the IMCgp100-202 trial registered as NCT03070392, in New England Journal of Medicine (2021), chosen as the most cited paper whose own text cites the registry id.

## Summary

Background: Uveal melanoma is a disease that is distinct from cutaneous melanoma, with a low tumor mutational burden and a 1-year overall survival of approximately 50% in patients with metastatic uveal melanoma. Data showing a proven overall survival benefit with a systemic treatment are lacking. Tebentafusp is a bispecific protein consisting of an affinity-enhanced T-cell receptor fused to an anti-CD3 effector that can redirect T cells to target glycoprotein 100-positive cells.

Methods: In this open-label, phase 3 trial, we randomly assigned previously untreated HLA-A*02:01-positive patients with metastatic uveal melanoma in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator's choice of therapy with single-agent pembrolizumab, ipilimumab, or dacarbazine (control group), stratified according to the lactate dehydrogenase level. The primary end point was overall survival.

Results: A total of 378 patients were randomly assigned to either the tebentafusp group (252 patients) or the control group (126 patients). Overall survival at 1 year was 73% in the tebentafusp group and 59% in the control group (hazard ratio for death, 0.51; 95% confidence interval [CI], 0.37 to 0.71; P<0.001) in the intention-to-treat population. Progression-free survival was also significantly higher in the tebentafusp group than in the control group (31% vs. 19% at 6 months; hazard ratio for disease progression or death, 0.73; 95% CI, 0.58 to 0.94; P = 0.01). The most common treatment-related adverse events in the tebentafusp group were cytokine-mediated events (due to T-cell activation) and skin-related events (due to glycoprotein 100-positive melanocytes), including rash (83%), pyrexia (76%), and pruritus (69%). These adverse events decreased in incidence and severity after the first three or four doses and infrequently led to discontinuation of the trial treatment (2%). No treatment-related deaths were reported.

Conclusions: Treatment with tebentafusp resulted in longer overall survival than the control therapy among previously untreated patients with metastatic uveal melanoma. (Funded by Immunocore; ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.).

Indexed on Europe PMC as PubMed record 34551229 (DOI 10.1056/nejmoa2103485). Its abstract cites the registry id NCT03070392, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2021
- DOI: 10.1056/nejmoa2103485
- Authors: Nathan P, Hassel JC, Rutkowski P, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT03070392 with the most citations, so it is the natural first reading for anyone following the IMCgp100-202 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- N Engl J Med 2021: https://doi.org/10.1056/nejmoa2103485
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34551229/
- Europe PMC: https://europepmc.org/article/MED/34551229
- ClinicalTrials.gov NCT03070392: https://clinicaltrials.gov/study/NCT03070392

## Connected records

- trials: [IMCgp100-202](https://onco.cc/trials/imcgp100-202/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- ideas: [TCR therapeutics for non-HLA-A*02 patients](https://onco.cc/ideas/idea-prame-tcr-beyond-a02/)

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