PMID- 38433375
OWN - NLM
STAT- MEDLINE
DCOM- 20240403
LR  - 20240403
IS  - 1346-8138 (Electronic)
IS  - 0385-2407 (Linking)
VI  - 51
IP  - 4
DP  - 2024 Apr
TI  - Safety and effectiveness of avelumab in patients with Merkel cell carcinoma in 
      general clinical practice in Japan: Post-marketing surveillance.
PG  - 475-483
LID - 10.1111/1346-8138.17096 [doi]
AB  - Avelumab, a programmed cell death ligand 1 blocking antibody, was approved for 
      its first indication in Japan in September 2017 to treat unresectable Merkel cell 
      carcinoma (MCC). Given that the pivotal JAVELIN Merkel 200 study only included a 
      few Japanese patients, this post-marketing surveillance (PMS) evaluated the 
      safety and effectiveness outcomes of patients with MCC who received avelumab in 
      general clinical practice in Japan. This prospective, non-comparative, 
      multicenter PMS included data from all patients with unresectable MCC who 
      received avelumab between November 22, 2017 (avelumab launch date) and October 
      31, 2019. The primary objective was to evaluate avelumab safety (i.e., adverse 
      events [AEs], adverse drug reactions [ADRs], and ADRs of safety specifications). 
      The secondary objective was to evaluate avelumab effectiveness (i.e., objective 
      response rate and overall survival [OS] rate). Seventy-five evaluable patients 
      were included, of whom 81.3% experienced AEs of any grade (57.3% experienced AEs 
      of grade >/= 3; 41.3% experienced AEs of grade 5) and 61.3% experienced ADRs (14.7% 
      experienced ADRs of grade >/= 3; no grade 5 ADRs were observed). The most common 
      ADRs were pyrexia (18.7%), infusion related reaction (10.7%), and chills (6.7%). 
      The most common ADRs of safety specifications were infusion reactions (any grade: 
      n = 21 [28.0%]; grade 3 or 4: n = 3 [4.0%]), thyroid dysfunction (n = 7 [9.3%]), 
      and hepatic function disorders (n = 4 [5.3%]). The median observation period was 
      51 weeks. An objective response was achieved by 34/75 patients (45.3%; complete 
      response, 24.0%; partial response, 21.3%) and 6- and 12-month OS rates were 77.7% 
      and 59.6%, respectively. This PMS confirmed the clinical tolerability and 
      effectiveness of avelumab in patients with MCC, with no new safety concerns. The 
      risk-benefit profile of avelumab was comparable with that observed in clinical 
      trials and remains favorable for use in general clinical practice in Japan.
CI  - (c) 2024 The Authors. The Journal of Dermatology published by John Wiley & Sons 
      Australia, Ltd on behalf of Japanese Dermatological Association.
FAU - Uhara, Hisashi
AU  - Uhara H
AUID- ORCID: 0000-0001-5391-3397
AD  - Sapporo Medical University School of Medicine, Sapporo, Hokkaido, Japan.
FAU - Kiyohara, Yoshio
AU  - Kiyohara Y
AD  - Shizuoka Cancer Center Hospital and Research Institute, Shizuoka, Japan.
FAU - Isei, Taiki
AU  - Isei T
AD  - Osaka International Cancer Institution, Osaka, Japan.
FAU - Nagase, Kotaro
AU  - Nagase K
AD  - Department of Dermatology, Saga-Ken Medical Centre Koseikan, Saga, Japan.
FAU - Kambe, Anzu
AU  - Kambe A
AD  - Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA.
FAU - Sato, Masashi
AU  - Sato M
AD  - Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA.
FAU - Tanaka, Yutaro
AU  - Tanaka Y
AD  - Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA.
FAU - Yamazaki, Naoya
AU  - Yamazaki N
AUID- ORCID: 0000-0002-9638-0428
AD  - National Cancer Center Hospital, Tokyo, Japan.
LA  - eng
GR  - Merck (CrossRef Funder ID: 10.13039/100009945)/
PT  - Journal Article
PT  - Multicenter Study
DEP - 20240303
PL  - England
TA  - J Dermatol
JT  - The Journal of dermatology
JID - 7600545
RN  - KXG2PJ551I (avelumab)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Merkel Cell/drug therapy/pathology
MH  - Japan
MH  - Antibodies, Monoclonal/adverse effects
MH  - Prospective Studies
MH  - *Skin Neoplasms/pathology
MH  - Product Surveillance, Postmarketing
MH  - *Antibodies, Monoclonal, Humanized
OTO - NOTNLM
OT  - Merkel cell carcinoma
OT  - avelumab
OT  - post-marketing
OT  - safety
OT  - treatment effectiveness
EDAT- 2024/03/04 06:50
MHDA- 2024/04/03 06:44
CRDT- 2024/03/04 00:33
PHST- 2023/12/11 00:00 [revised]
PHST- 2023/07/19 00:00 [received]
PHST- 2023/12/18 00:00 [accepted]
PHST- 2024/04/03 06:44 [medline]
PHST- 2024/03/04 06:50 [pubmed]
PHST- 2024/03/04 00:33 [entrez]
AID - 10.1111/1346-8138.17096 [doi]
PST - ppublish
SO  - J Dermatol. 2024 Apr;51(4):475-483. doi: 10.1111/1346-8138.17096. Epub 2024 Mar 
      3.