open access

Ahead of print
Review paper
Published online: 2022-09-09
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Avelumab use in Merkel cell carcinoma treatment

Monika Dudzisz-Śledź1, Martyna Zwierzchowska1, Elżbieta Bylina1, Piotr Rutkowski1, Anna M. Czarnecka1
DOI: 10.5603/NJO.a2022.0048
Affiliations
  1. Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

open access

Ahead of print
Review article
Published online: 2022-09-09

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 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 earlywith the median time to response of 6.1 week. PFS rate at 6 months and at 12 months are 41% and 31%, respectively. Median OS is 20.3 months. The OS rate at 1 year is 60%.

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 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 earlywith the median time to response of 6.1 week. PFS rate at 6 months and at 12 months are 41% and 31%, respectively. Median OS is 20.3 months. The OS rate at 1 year is 60%.

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Keywords

Merkel; avelumab; immunotherapy; skin

About this article
Title

Avelumab use in Merkel cell carcinoma treatment

Journal

Nowotwory. Journal of Oncology

Issue

Ahead of print

Article type

Review paper

Published online

2022-09-09

Page views

19

Article views/downloads

13

DOI

10.5603/NJO.a2022.0048

Keywords

Merkel
avelumab
immunotherapy
skin

Authors

Monika Dudzisz-Śledź
Martyna Zwierzchowska
Elżbieta Bylina
Piotr Rutkowski
Anna M. Czarnecka

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