Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East
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Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East. / Ascierto, Paolo Antonio; Orlova, Kristina; Grignani, Giovanni; Dudzisz-Śledź, Monika; Fenig, Eyal; Chiarion Sileni, Vanna; Fazio, Nicola; Samimi, Mahtab; Mortier, Laurent; Gebhardt, Christoffer; Kramkimel, Nora; Steven, Neil; Bechter, Oliver; Arance, Ana; Benincasa, Elena; Kostkova, Lenka; Costa, Nuno; Lorigan, Paul.
in: INT J CANCER, Jahrgang 149, Nr. 11, 01.12.2021, S. 1926-1934.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Avelumab expanded access program in metastatic Merkel cell carcinoma: Efficacy and safety findings from patients in Europe and the Middle East
AU - Ascierto, Paolo Antonio
AU - Orlova, Kristina
AU - Grignani, Giovanni
AU - Dudzisz-Śledź, Monika
AU - Fenig, Eyal
AU - Chiarion Sileni, Vanna
AU - Fazio, Nicola
AU - Samimi, Mahtab
AU - Mortier, Laurent
AU - Gebhardt, Christoffer
AU - Kramkimel, Nora
AU - Steven, Neil
AU - Bechter, Oliver
AU - Arance, Ana
AU - Benincasa, Elena
AU - Kostkova, Lenka
AU - Costa, Nuno
AU - Lorigan, Paul
N1 - © 2021 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antibodies, Monoclonal, Humanized/adverse effects
KW - Antineoplastic Agents, Immunological/adverse effects
KW - Carcinoma, Merkel Cell/drug therapy
KW - Compassionate Use Trials
KW - Europe
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Middle East
KW - Skin Neoplasms/drug therapy
KW - Treatment Outcome
U2 - 10.1002/ijc.33746
DO - 10.1002/ijc.33746
M3 - SCORING: Journal article
C2 - 34310716
VL - 149
SP - 1926
EP - 1934
JO - INT J CANCER
JF - INT J CANCER
SN - 0020-7136
IS - 11
ER -
