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

Paolo Antonio Ascierto, Kristina Orlova, Giovanni Grignani, Monika Dudzisz-Śledź, Eyal Fenig, Vanna Chiarion Sileni, Nicola Fazio, Mahtab Samimi, Laurent Mortier, Christoffer Gebhardt, Nora Kramkimel, Neil Steven, Oliver Bechter, Ana Arance, Elena Benincasa, Lenka Kostkova, Nuno Costa, Paul Lorigan*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1926-1934
Number of pages9
JournalInternational Journal of Cancer
Volume149
Issue number11
DOIs
StatePublished - 1 Dec 2021

Funding

FundersFunder number
healthcare business of Merck KGaA
Merck KGaA

    Keywords

    • Merkel cell carcinoma
    • PD-L1
    • avelumab
    • expanded access program
    • second-line

    Fingerprint

    Dive into the research topics of 'Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East'. Together they form a unique fingerprint.

    Cite this