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Avelumab in patients with previously treated metastatic Merkel cell carcinoma (JAVELIN Merkel 200): updated overall survival data after >5 years of follow-up.
D'Angelo, S P; Bhatia, S; Brohl, A S; Hamid, O; Mehnert, J M; Terheyden, P; Shih, K C; Brownell, I; Lebbé, C; Lewis, K D; Linette, G P; Milella, M; Xiong, H; Guezel, G; Nghiem, P T.
Afiliación
  • D'Angelo SP; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, USA. Electronic address: dangelos@mskcc.org.
  • Bhatia S; Department of Medicine, University of Washington Medical Center, Seattle, USA.
  • Brohl AS; Sarcoma Department and Cutaneous Oncology, Moffitt Cancer Center, Tampa, USA.
  • Hamid O; Department of Medical Oncology, The Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, USA.
  • Mehnert JM; Division of Medical Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, USA.
  • Terheyden P; Department of Dermatology, University of Lübeck, Lübeck, Germany.
  • Shih KC; Department of Medical Oncology, Sarah Cannon Research Institute, Nashville, USA; Department of Medical Oncology, Tennessee Oncology, Nashville, USA.
  • Brownell I; Dermatology Branch, National Institutes of Health, Bethesda, USA.
  • Lebbé C; Université de Paris, INSERM U976, Paris, France; Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France.
  • Lewis KD; Department of Medicine, University of Colorado Denver School of Medicine, Aurora, USA.
  • Linette GP; Center for Cellular Immunotherapies, University of Pennsylvania, Philadelphia, USA.
  • Milella M; Section of Oncology, Department of Medicine, University of Verona School of Medicine and Verona University Hospital Trust (AOUI Verona), Verona, Italy.
  • Xiong H; Biostatistics, EMD Serono Research & Development Institute, Inc., Billerica, USA, an affiliate of Merck KGaA.
  • Guezel G; Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany.
  • Nghiem PT; Division of Dermatology, Department of Medicine, University of Washington Medical Center at South Lake Union, Seattle, USA.
ESMO Open ; 6(6): 100290, 2021 12.
Article en En | MEDLINE | ID: mdl-34715570
BACKGROUND: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer that has a poor prognosis in patients with advanced disease. Avelumab [anti-programmed death-ligand 1 (PD-L1)] became the first approved treatment for patients with metastatic MCC (mMCC), based on efficacy and safety data observed in the JAVELIN Merkel 200 trial. We report long-term overall survival (OS) data after >5 years of follow-up from the cohort of patients with mMCC whose disease had progressed after one or more prior lines of chemotherapy. PATIENTS AND METHODS: In Part A of the single-arm, open-label, phase II JAVELIN Merkel 200 trial, patients with mMCC that had progressed following one or more prior lines of chemotherapy received avelumab 10 mg/kg by intravenous infusion every 2 weeks until confirmed disease progression, unacceptable toxicity, or withdrawal. In this analysis, long-term OS was analyzed. RESULTS: In total, 88 patients were treated with avelumab. At data cut-off (25 September 2020), median follow-up was 65.1 months (range 60.8-74.1 months). One patient (1.1%) remained on treatment, and an additional patient (1.1%) had reinitiated avelumab after previously discontinuing treatment. Median OS was 12.6 months [95% confidence interval (CI) 7.5-17.1 months], with a 5-year OS rate of 26% (95% CI 17% to 36%). In patients with PD-L1+ versus PD-L1- tumors, median OS was 12.9 months (95% CI 8.7-29.6 months) versus 7.3 months (95% CI 3.4-14.0 months), and the 5-year OS rate was 28% (95% CI 17% to 40%) versus 19% (95% CI 5% to 40%), respectively (HR 0.67; 95% CI 0.36-1.25). CONCLUSION: Avelumab monotherapy resulted in meaningful long-term OS in patients with mMCC whose disease had progressed following chemotherapy. These results further support the role of avelumab as a standard of care for patients with mMCC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Carcinoma de Células de Merkel Tipo de estudio: Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: ESMO Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Carcinoma de Células de Merkel Tipo de estudio: Observational_studies / Prognostic_studies Límite: Humans Idioma: En Revista: ESMO Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido