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The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma

Open access
Hassel, Jessica C., Piperno-Neumann, Sophie, Rutkowski, Piotr, Baurain, Jean-Francois, Schlaak, Max, Butler, Marcus O., Sullivan, Ryan J., Dummer, Reinhard, Kirkwood, John M., Orloff, Marlana, Sacco, Joseph J., Ochsenreither, Sebastian, Joshua, Anthony M., Gastaud, Lauris, Curti, Brendan, Piulats, Josep M., Salama, April K.S., Shoushtari, Alexander N., Demidov, Lev, Milhem, Mohammed, Chmielowski, Bartosz, Kim, Kevin B., Carvajal, Richard D., Hamid, Omid, Collins, Laura, Ranade, Koustubh, Holland, Chris, Pfeiffer, Constance, Nathan, Paul·2023·New England Journal of Medicine

Abstract

BACKGROUND: Tebentafusp, a T-cell receptor-bispecific molecule that targets glycoprotein 100 and CD3, is approved for adult patients who are positive for HLA-A*02:01 and have unresectable or metastatic uveal melanoma. The primary analysis in the present phase 3 trial supported a long-term survival benefit associated with the drug. METHODS: We report the 3-year efficacy and safety results from our open-label, phase 3 trial in which HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma were randomly assigned in a 2:1 ratio to receive tebentafusp (tebentafusp group) or the investigator's choice of therapy with pembrolizumab, ipilimumab, or dacarbazine (control group), with randomization stratified according to the lactate dehydrogenase level. The primary end point was overall survival. RESULTS: At a minimum follow-up of 36 months, median overall survival was 21.6 months in the tebentafusp group and 16.9 months in the control group (hazard ratio for death, 0.68; 95% confidence interval, 0.54 to 0.87). The estimated percentage of patients surviving at 3 years was 27% in the tebentafusp group and 18% in the control group. The most common treatment-related adverse events of any grade in the tebentafusp group were rash (83%), pyrexia (76%), pruritus (70%), and hypotension (38%). Most tebentafusp-related adverse events occurred early during treatment, and no new adverse events were observed with long-term administration. The percentage of patients who discontinued treatment because of adverse events continued to be low in both treatment groups (2% in the tebentafusp group and 5% in the control group). No treatment-related deaths occurred. CONCLUSIONS: This 3-year analysis supported a continued long-term benefit of tebentafusp for overall survival among adult HLA-A*02:01-positive patients with previously untreated metastatic uveal melanoma. (Funded by Immunocore; IMCgp100-202 ClinicalTrials.gov number, NCT03070392; EudraCT number, 2015-003153-18.).

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Metadata

Authors
Hassel, J. C., Piperno-Neumann, S., Rutkowski, P., Baurain, J.-F., Schlaak, M., Butler, M. O., Sullivan, R. J., Dummer, R., Kirkwood, J. M., Orloff, M., Sacco, J. J., Ochsenreither, S., Joshua, A. M., Gastaud, L., Curti, B., Piulats, J. M., Salama, A. K. S., Shoushtari, A. N., Demidov, L., Milhem, M., Chmielowski, B., Kim, K. B., Carvajal, R. D., Hamid, O., Collins, L., Ranade, K., Holland, C., Pfeiffer, C., & Nathan, P.
Venue
New England Journal of Medicine
Published
2023-12-14
Volume
389
Issue
24
Pages
2256-2266
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W4387845260
Cited by
284
References
21
FWCI
58.22
Type
journal article
Language
en
Open access
green

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CoChat. (2026). Citation check: Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma. https://app.cochat.ai/papers/10.1056/nejmoa2304753
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Hassel, J. C., Piperno-Neumann, S., Rutkowski, P., Baurain, J.-F., Schlaak, M., Butler, M. O., Sullivan, R. J., Dummer, R., Kirkwood, J. M., Orloff, M., Sacco, J. J., Ochsenreither, S., Joshua, A. M., Gastaud, L., Curti, B., Piulats, J. M., Salama, A. K. S., Shoushtari, A. N., Demidov, L., . . . Nathan, P. (2023). Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2304753

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.