PMID- 34461272 OWN - NLM STAT- MEDLINE DCOM- 20211012 LR - 20211012 IS - 1879-0461 (Electronic) IS - 1040-8428 (Linking) VI - 166 DP - 2021 Oct TI - Efficacy and safety profile of avelumab monotherapy. PG - 103464 LID - S1040-8428(21)00251-1 [pii] LID - 10.1016/j.critrevonc.2021.103464 [doi] AB - Avelumab can kill cancer cells through immune checkpoint inhibition and antibody-dependent cell-mediated cytotoxicity (ADCC). Here, we analyzed the clinical efficacy and adverse events (AEs) in 3935 cancer patients from 21 trials. Compared with conventional treatment, avelumab monotherapy was associated with more tumor responses and less AEs. The pooled objective response rate was 14.18 % (95 % CI, 10.68 %-18.08 %). More PD-L1 positive patients responded to avelumab monotherapy compared to PD-L1 negative patients. The overall incidence was 73.78 % for all-grade treatment-related AE (TRAE), 14.44 % for high-grade TRAE, 6.07 % for serious adverse event, 0.44 % for fatal adverse event, 17.86 % for all-grade immune-related AE (irAE), and 3.22 % for high-grade irAE. In summary, avelumab monotherapy presents an active anti-tumor activity, shows no sign of increased toxicity due to the ADCC. These characteristics provide rational for further application of avelumab in cancer treatment. CI - Copyright (c) 2021 Elsevier B.V. All rights reserved. FAU - Zhao, Bin AU - Zhao B AD - The Second Affiliated Hospital & Yuying Children's Hospital, Wenzhou Medical University, Wenzhou, 325027, China. Electronic address: doctorbinzhao@126.com. FAU - Gao, Meiling AU - Gao M AD - The Second Affiliated Hospital & Yuying Children's Hospital, Wenzhou Medical University, Wenzhou, 325027, China. FAU - Zhao, Hong AU - Zhao H AD - The Cancer Center of the Fifth Affiliated Hospital, Sun Yat-Sen University, Zhuhai, 519001, China. FAU - Zhao, Jiaxin AU - Zhao J AD - Zhuhai People's Hospital, Zhuhai Hospital Affiliated with Jinan University, Zhuhai, 519001, China. FAU - Shen, Xian AU - Shen X AD - The Second Affiliated Hospital & Yuying Children's Hospital, Wenzhou Medical University, Wenzhou, 325027, China. Electronic address: doctorxianshen@163.com. LA - eng PT - Journal Article PT - Review DEP - 20210828 PL - Netherlands TA - Crit Rev Oncol Hematol JT - Critical reviews in oncology/hematology JID - 8916049 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (B7-H1 Antigen) RN - KXG2PJ551I (avelumab) SB - IM MH - *Antibodies, Monoclonal/adverse effects MH - Antibodies, Monoclonal, Humanized/adverse effects MH - Antibody-Dependent Cell Cytotoxicity MH - *B7-H1 Antigen MH - Humans OTO - NOTNLM OT - Avelumab OT - Checkpoint inhibitors OT - Efficacy OT - Immunotherapy OT - Safety OT - Toxicity profile EDAT- 2021/08/31 06:00 MHDA- 2021/10/13 06:00 CRDT- 2021/08/30 20:14 PHST- 2019/04/30 00:00 [received] PHST- 2021/03/11 00:00 [revised] PHST- 2021/08/19 00:00 [accepted] PHST- 2021/08/31 06:00 [pubmed] PHST- 2021/10/13 06:00 [medline] PHST- 2021/08/30 20:14 [entrez] AID - S1040-8428(21)00251-1 [pii] AID - 10.1016/j.critrevonc.2021.103464 [doi] PST - ppublish SO - Crit Rev Oncol Hematol. 2021 Oct;166:103464. doi: 10.1016/j.critrevonc.2021.103464. Epub 2021 Aug 28.