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- Title
Avelumab use in Merkel cell carcinoma treatment.
- Authors
Dudzisz-Śledź, Monika; Zwierzchowska, Martyna; Bylina, Elżbieta; Rutkowski, Piotr; Czarnecka, Anna M.
- Abstract
Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. It was the first immunotherapy to be approved for the treatment of MCC. In March 2017, the FDA granted accelerated approval to avelumab for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) –irrespective of prior therapy. In July 2017, the European Medicines Agency (EMA) recommended the approval of avelumab as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC). Approvals were based on the efficacy and safety demonstrated in JAVELIN Merkel 200 (NCT02155647), a multi-center, open-label, single-arm, phase II clinical trial [1]. Part A of the study consisted of patients treated in the second line with metastatic, chemotherapy-refractory MCC. Part B consisted of systemic treatment-naive patients who received avelumab as a first-line treatment for metastatic or distally recurrent MCC. In the first line the ORR is 39.7%. Durable responses lasting at least 6 months were observed and the majority of responses are observed early with the median time to response of 6.1 week. PFS rate at 6 and 12 months are 41% and 31%, respectively. Median OS is 20.3 months. The OS rate at 1 year is 60%.
- Subjects
MERKEL cell carcinoma; EUROPEAN Medicines Agency; UNITED States. Food &; Drug Administration; PROGRAMMED death-ligand 1; CHILD patients; TREATMENT effectiveness; PEDIATRIC therapy
- Publication
Nowotwory, 2022, Vol 72, Issue 6, p365
- ISSN
0029-540X
- Publication type
Article
- DOI
10.5603/NJO.a2022.0048