Avelumab expanded access program in metastatic Merkel cell carcinoma: efficacy and safety findings from patients in Europe and the Middle East
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
Affiliation
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.Issue Date
2021
Metadata
Show full item recordAbstract
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 CancerDOI
10.1002/ijc.33746PubMed ID
34310716Additional Links
https://dx.doi.org/10.1002/ijc.33746Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1002/ijc.33746
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