Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma
Open accessAbstract
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.).
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Tebentafusp-tebn, a soluble TCR-anti-CD3 fusion protein targeting gp100, is approved for metastatic uveal melanoma based on an overall survival benefit in a phase III trial.
“Notably, tebentafusp-tebn, a bispecific fusion protein consisting of a soluble TCR specific to gp100 (expressed by melanoma cells) linked to an anti-CD3 single-chain antibody fragment that targets T cells, has been approved for the treatment of metastatic uveal melanoma based on an OS benefit observed in a phase III trial199.”
From The current state of the art and future trends in RAS-targeted cancer therapies (2022) · cites this paper as [199]
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- Authors
- Nathan, P., Hassel, J. C., Rutkowski, P., Baurain, J.-F., Butler, M. O., Schlaak, M., Sullivan, R. J., Ochsenreither, S., Dummer, R., Kirkwood, J. M., Joshua, A. M., Sacco, J. J., Shoushtari, A. N., Orloff, M., Piulats, J. M., Milhem, M., Salama, A. K. S., Curti, B., Demidov, L., Gastaud, L., Mauch, C., Yushak, M., Carvajal, R. D., Hamid, O., Abdullah, S. E., Holland, C., Goodall, H., & Piperno-Neumann, S.
- Affiliations
- University of Liverpool (GB)
- From Mount Vernon Cancer Centre, Northwood (P.N.), the Clatterbridge Cancer Centre NHS Foundation Trust, Wirral (J.J.S.), the University of Liverpool, Liverpool (J.J.S.), and Immunocore, Abingdon (S.E.A., C.H., H.G.) — all in the United Kingdom; the Department of Dermatology and the National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg (J.C.H.), the Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich, Munich (M.S.), the Department of Hematology and Oncology, Charité–Comprehensive Cancer Center (S.O.), Berlin, and the Department of Dermatology and the Center for Integrated Oncology, University Hospital Cologne, Cologne (C.M.) — all in Germany; Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); Institut Roi Albert II des Cliniques Universitaires Saint-Luc and Université Catholique de Louvain, Brussels (J.-F.B.); Princess Margaret Cancer Centre, Toronto (M.O.B.); Massachusetts General Hospital Cancer Ce...
- Memorial Sloan Kettering Cancer Center (US)
- ORCID
- Nathan, Paul
- Hassel, Jessica C.
- Rutkowski, Piotr
- Butler, Marcus O.
- Schlaak, Max
- Sullivan, Ryan J.
- Ochsenreither, Sebastian
- Dummer, Reinhard
- Kirkwood, John M.
- Joshua, Anthony M.
- Sacco, Joseph J.
- Shoushtari, Alexander N.
- Orloff, Marlana
- Piulats, Josep M.
- Milhem, Mohammed
- Salama, April K.S.
- Curti, Brendan
- Mauch, Cornelia
- Yushak, Melinda
- Carvajal, Richard D.
- Hamid, Omid
- Abdullah, Shaad E.
- Piperno-Neumann, Sophie
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-09-23
- Volume
- 385
- Issue
- 13
- Pages
- 1196-1206
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3200574709
- Cited by
- 924
- References
- 28
- Citations by year
- 2026: 158 · 2025: 181 · 2024: 216 · 2023: 205 · 2022: 148 · 2021: 15
- FWCI
- 131.08
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion, other-oa)
- Dipòsit Digital de la Universitat de Barcelona (Universitat de Barcelona) (submittedVersion, public-domain)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Health Sciences › Medicine › Ophthalmology › Ocular Oncology and Treatments
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Keywords
- metastatic uveal melanoma, bispecific T-cell engagers, anti-CD3 antibody, pembrolizumab, ipilimumab, dacarbazine, overall survival, progression-free survival, HLA-A*0201, cytokine release syndrome, treatment-related adverse events, treatment-naive patients
- MeSH terms
- Ipilimumab, Cytokine Release Syndrome, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Dacarbazine, Exanthema, Female, Humans, Male, Melanoma, Middle Aged, Recombinant Fusion Proteins, Uveal Neoplasms, Survival Analysis, Antibodies, Monoclonal, Humanized
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