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Published on: October 27, 2014
Three-Year Overall Survival with Tebentafusp in Metastatic Uveal Melanoma
Jessica C Hassel1, Sophie Piperno-Neumann1, Piotr Rutkowski1
1From the University Hospital Heidelberg, Heidelberg (J.C.H.), the Department of Dermatology and Allergy, University Hospital, Ludwig Maximilian University of Munich, Munich (M.S.), and the Department of Dermatology, Venereology, and Allergology (M.S.) and the Department of Hematology, Oncology, and Tumor Immunology and the Comprehensive Cancer Center (S.O.), Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and the Department of Hematology, Oncology, and Tumor Immunology and the Comprehensive Cancer Center, Berlin Institute of Health (S.O.), Berlin - all in Germany; Institut Curie, Paris (S.P.-N.), and Centre Antoine Lacassagne, Nice (L.G.) - both in France; Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (P.R.); Institut Roi Albert II Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels (J.-F.B.); Princess Margaret Cancer Centre, the Department of Medical Oncology and Hematology, and the Department of Immunology, University of Toronto, Toronto (M.O.B.); Massachusetts General Hospital and Dana-Farber Cancer Institute - both in Boston (R.J.S.); University of Zürich Hospital, Zürich, Switzerland (R.D.); University of Pittsburgh Medical Center, Pittsburgh (J.M.K.), Sidney Kimmel Cancer Center, Jefferson University, Philadelphia (M.O.), and Immunocore, Conshohocken (C.P.) - all in Pennsylvania; the Clatterbridge Cancer Centre NHS Foundation Trust, Wirral (J.J.S.), University of Liverpool, Liverpool (J.J.S.), Immunocore, Abingdon-on-Thames (L.C.), and Mount Vernon Cancer Centre, Northwood and UCLH, London (P.N.) - all in the United Kingdom; Kinghorn Cancer Centre, Saint Vincent's Hospital, Darlinghurst, NSW, Australia (A.M.J.); Providence Portland Medical Center, Portland, OR (B. Curti); Institut Català d'Oncologia and the Cancer Immunotherapy Group, OncoBell, Institut d'Investigació Biomèdica de Bellvitge, Barcelona, and Centro de Investigación Biomédica en Red de Cáncer, Madrid - all in Spain (J.M.P.); Duke University, Durham, NC (A.K.S.S.); Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York (A.N.S.), and Northwell Health Cancer Institute, New Hyde Park (R.D.C.) - all in New York; N.N. Blokhin National Medical Research Center of Oncology, Moscow (L.D.); University of Iowa Hospitals and Clinics, Iowa City (M.M.); Jonsson Comprehensive Cancer Center, University of California (B. Chmielowski), and the Angeles Clinic and Research Institute, Cedars-Sinai Affiliate (O.H.), Los Angeles, and California Pacific Medical Center, San Francisco (K.B.K.); and Immunocore, Rockville, MD (K.R., C.H.).
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.).
