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Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial.
Carvajal, Richard D; Butler, Marcus O; Shoushtari, Alexander N; Hassel, Jessica C; Ikeguchi, Alexandra; Hernandez-Aya, Leonel; Nathan, Paul; Hamid, Omid; Piulats, Josep M; Rioth, Matthew; Johnson, Douglas B; Luke, Jason J; Espinosa, Enrique; Leyvraz, Serge; Collins, Laura; Goodall, Howard M; Ranade, Koustubh; Holland, Chris; Abdullah, Shaad E; Sacco, Joseph J; Sato, Takami.
Afiliación
  • Carvajal RD; Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.
  • Butler MO; Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
  • Shoushtari AN; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • Hassel JC; Weill Cornell Medical College, New York, NY, USA.
  • Ikeguchi A; University Hospital Heidelberg, Heidelberg, Germany.
  • Hernandez-Aya L; Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.
  • Nathan P; Washington University School of Medicine, Saint Louis, MO, USA.
  • Hamid O; Mount Vernon Cancer Centre - East and North Herts NHS Trust, Northwood, Middlesex, UK.
  • Piulats JM; The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, CA, USA.
  • Rioth M; Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), Hospitalet de Llobregat, Barcelona, Spain.
  • Johnson DB; UC Cancer Center, University of Colorado, Aurora, CO, USA.
  • Luke JJ; Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.
  • Espinosa E; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.
  • Leyvraz S; Hospital Universitario La Paz - CIBERONC, Madrid, Spain.
  • Collins L; Charité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
  • Goodall HM; Immunocore, Abingdon-on-Thames, UK.
  • Ranade K; Immunocore, Abingdon-on-Thames, UK.
  • Holland C; Immunocore, Rockville, MD, USA.
  • Abdullah SE; Immunocore, Rockville, MD, USA.
  • Sacco JJ; Immunocore, Rockville, MD, USA.
  • Sato T; Clatterbridge Cancer Center - NHS Foundation Trust, Wirral, UK.
Nat Med ; 28(11): 2364-2373, 2022 11.
Article en En | MEDLINE | ID: mdl-36229663
In patients with previously treated metastatic uveal melanoma, the historical 1 year overall survival rate is 37% with a median overall survival of 7.8 months. We conducted a multicenter, single-arm, open-label phase 2 study of tebentafusp, a soluble T cell receptor bispecific (gp100×CD3), in 127 patients with treatment-refractory metastatic uveal melanoma (NCT02570308). The primary endpoint was the estimation of objective response rate based on RECIST (Response Evaluation Criteria in Solid Tumours) v1.1. Secondary objectives included safety, overall survival, progression-free survival and disease control rate. All patients had at least one treatment-related adverse event, with rash (87%), pyrexia (80%) and pruritus (67%) being the most common. Toxicity was mostly mild to moderate in severity but was greatly reduced in incidence and intensity after the initial three doses. Despite a low overall response rate of 5% (95% CI: 2-10%), the 1 year overall survival rate was 62% (95% CI: 53-70%) with a median overall survival of 16.8 months (95% CI: 12.9-21.3), suggesting benefit beyond traditional radiographic-based response criteria. In an exploratory analysis, early on-treatment reduction in circulating tumour DNA was strongly associated with overall survival, even in patients with radiographic progression. Our findings indicate that tebentafusp has promising clinical activity with an acceptable safety profile in patients with previously treated metastatic uveal melanoma, and data suggesting ctDNA as an early indicator of clinical benefit from tebentafusp need confirmation in a randomized trial.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Úvea / Melanoma Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Úvea / Melanoma Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Nat Med Asunto de la revista: BIOLOGIA MOLECULAR / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos