• Login
    View Item 
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    •   Home
    • The Christie Research Publications Repository
    • All Christie Publications
    • View Item
    JavaScript is disabled for your browser. Some features of this site may not work without it.

    Browse

    All of ChristieCommunitiesTitleAuthorsIssue DateSubmit DateSubjectsThis CollectionTitleAuthorsIssue DateSubmit DateSubjects

    My Account

    LoginRegister

    Local Links

    The Christie WebsiteChristie Library and Knowledge Service

    Statistics

    Display statistics

    Avelumab expanded access program in metastatic Merkel cell carcinoma: efficacy and safety findings from patients in Europe and the Middle East

    • CSV
    • RefMan
    • EndNote
    • BibTex
    • RefWorks
    Thumbnail
    Name:
    34310716.pdf
    Size:
    11.28Mb
    Format:
    PDF
    Description:
    From UNPAYWALL
    Download
    Authors
    Ascierto, P. A.
    Orlova, K.
    Grignani, G.
    Dudzisz-Śledź, M.
    Fenig, E.
    Chiarion Sileni, V.
    Fazio, N.
    Samimi, M.
    Mortier, L.
    Gebhardt, C.
    Kramkimel, N.
    Steven, N.
    Bechter, O.
    Arance, A.
    Benincasa, E.
    Kostkova, L.
    Costa, N
    Lorigan, Paul C
    Show allShow less
    Affiliation
    Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.
    Issue Date
    2021
    
    Metadata
    Show full item record
    Abstract
    Incidence rates of Merkel cell carcinoma (MCC), an uncommon skin cancer with an aggressive disease course, have increased in recent decades. Limited treatment options are available for patients with metastatic MCC (mMCC). Avelumab, an anti-programmed cell death-ligand 1 monoclonal antibody, became the first approved treatment for mMCC after the results of the phase 2 JAVELIN Merkel 200 study. Prior to its regulatory approval, an expanded access program (EAP) enabled compassionate use of avelumab in patients with mMCC. Here we report findings from patients enrolled in the EAP in Europe and the Middle East. Efficacy and safety data were provided at the discretion of treating physicians. Between March 2, 2016, and December 22, 2018, 403 requests for avelumab were received from 21 countries, and avelumab was supplied to 335 patients. Most patients (96.7%) received avelumab as second-line or later treatment. In 150 patients for whom response data were available, the objective response rate was 48.0%, and in responding patients, median duration of treatment was 7.4 months (range, 1.0-41.7 months). The most common treatment-related adverse events were infusion-related reaction (2.4%) and pyrexia (2.1%), and no new safety signals were observed. Overall, results from European and Middle Eastern patients enrolled in this EAP confirm the efficacy and safety of avelumab treatment observed in previous studies in patients with mMCC.
    Citation
    Ascierto PA, Orlova K, Grignani G, Dudzisz‐Śledź M, Fenig E, Chiarion Sileni V, et al. Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East. Int J Cancer. 2021 Aug 3.
    Journal
    International Journal of Cancer
    URI
    http://hdl.handle.net/10541/624460
    DOI
    10.1002/ijc.33746
    PubMed ID
    34310716
    Additional Links
    https://dx.doi.org/10.1002/ijc.33746
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1002/ijc.33746
    Scopus Count
    Collections
    All Christie Publications

    entitlement

    Related articles

    • Avelumab treatment in Italian patients with metastatic Merkel cell carcinoma: experience from an expanded access program.
    • Authors: Grignani G, Chiarion Sileni V, Pinto C, Depenni R, Fazio N, Galli L, Giuffrida D, Carnaghi C, Ciliberto D, Corsi DC, Queirolo P, Benincasa E, Venturini F, Fazzi G, Costa N, Ascierto PA
    • Issue date: 2021 Feb 15
    • Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial.
    • Authors: D'Angelo SP, Russell J, Lebbé C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL
    • Issue date: 2018 Sep 1
    • Merkel cell carcinoma in Latin America: a contribution from an expanded access program for avelumab to address issues from experts' recommendations.
    • Authors: Munhoz RR, Cayol F, Corrales L, Gerson R, Tilli M, Barreto EO, Sánchez Castillo JO, Schmerling RA, Cinat G
    • Issue date: 2021 Apr
    • Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma: experience from a global expanded access program.
    • Authors: Walker JW, Lebbé C, Grignani G, Nathan P, Dirix L, Fenig E, Ascierto PA, Sandhu S, Munhoz R, Benincasa E, Flaskett S, Reed J, Engelsberg A, Hariharan S, Kasturi V
    • Issue date: 2020 Apr
    • Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel.
    • Authors: Cowey CL, Liu FX, Kim R, Boyd M, Fulcher N, Krulewicz S, Kasturi V, Bhanegaonkar A
    • Issue date: 2021 Jun
    DSpace software (copyright © 2002 - 2023)  DuraSpace
    Quick Guide | Contact Us
    Open Repository is a service operated by 
    Atmire NV
     

    Export search results

    The export option will allow you to export the current search results of the entered query to a file. Different formats are available for download. To export the items, click on the button corresponding with the preferred download format.

    By default, clicking on the export buttons will result in a download of the allowed maximum amount of items.

    To select a subset of the search results, click "Selective Export" button and make a selection of the items you want to export. The amount of items that can be exported at once is similarly restricted as the full export.

    After making a selection, click one of the export format buttons. The amount of items that will be exported is indicated in the bubble next to export format.