PMID- 34185953
OWN - NLM
STAT- MEDLINE
DCOM- 20220524
LR  - 20220731
IS  - 1743-7563 (Electronic)
IS  - 1743-7555 (Print)
IS  - 1743-7555 (Linking)
VI  - 18
IP  - 3
DP  - 2022 Jun
TI  - Efficacy and safety of blinatumomab: Post hoc pooled analysis in Asian adults 
      with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
PG  - 311-318
LID - 10.1111/ajco.13609 [doi]
AB  - BACKGROUND: Global studies have demonstrated the efficacy and safety of 
      blinatumomab-a BiTE((R)) (bispecific T-cell engager) targeted immuno-oncology 
      therapy that mediates the lysis of cells expressing CD19 in patients with 
      relapsed/refractory acute lymphoblastic leukemia (R/R ALL). Because limited data 
      are available in Asian patients, we conducted a post hoc pooled analysis in 45 
      Asian adult patients with R/R ALL-19 from the blinatumomab arm of TOWER 
      (NCT02013167) and 26 from Study 265, a phase 1b/2 study in Japanese adults 
      (NCT02412306). METHODS: Patients received a maximum of two cycles of induction 
      blinatumomab for 4 weeks by continuous intravenous infusion (cycle 1/week 1: 9 
      mug/day; cycle 1/weeks 2-4: 28 mug/day) followed by 2 weeks of no blinatumomab 
      (each 6-week cycle); patients received 28 mug/day blinatumomab in subsequent 
      cycles. RESULTS: Twenty of 45 patients enrolled (44%) achieved complete remission 
      with full or partial hematologic recovery compared with 44% in TOWER and 80% and 
      38% in phase 1b and phase 2, respectively, of Study 265. The Kaplan-Meier (KM) 
      median overall survival was 11.9 months (95% confidence interval [CI], 9.9-17.1) 
      and the KM median duration of relapse-free survival was 8.9 months (95% CI, 
      3.8-10.7). Ninety-three percent of patients had grade >/= 3 treatment-emergent 
      adverse events (AEs) compared with 87% in TOWER and 80% and 100% in phase 1b and 
      phase 2, respectively, of Study 265. Five patients (11.4%) had fatal AEs. 
      CONCLUSIONS: The safety and efficacy of blinatumomab in Asian patients were 
      comparable with those reported in previous global studies with no new safety 
      signals.
CI  - (c) 2021 The Authors. Asia-Pacific Journal of Clinical Oncology published by John 
      Wiley & Sons Australia, Ltd.
FAU - Kobayashi, Yukio
AU  - Kobayashi Y
AD  - National Cancer Center Hospital, Tokyo, Japan.
AD  - International University of Health and Welfare, Mita Hospital, Tokyo, Japan.
FAU - Oh, Iekuni
AU  - Oh I
AD  - Jichi Medical University, Tochigi, Japan.
FAU - Miyamoto, Toshihiro
AU  - Miyamoto T
AD  - Department of Medicine and Biosystemic Science, Kyushu University Graduate School 
      of Medical Science, Fukuoka, Japan.
FAU - Lee, Won-Sik
AU  - Lee WS
AD  - Department of Internal Medicine, Hemato-Oncology, Busan Paik Hospital, Inje 
      University, Busan, Korea.
FAU - Iida, Hiroatsu
AU  - Iida H
AD  - National Hospital Organization Nagoya Medical Center, Aichi, Japan.
FAU - Minami, Hironobu
AU  - Minami H
AD  - Medical Oncology/Hematology, Kobe University Graduate School of Medicine and 
      Hospital, Kobe, Japan.
FAU - Maeda, Yoshinobu
AU  - Maeda Y
AD  - Okayama University Hospital, Okayama, Japan.
FAU - Jang, Jun Ho
AU  - Jang JH
AD  - Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University 
      College of Medicine, Seoul, Korea.
FAU - Yoon, Sung-Soo
AU  - Yoon SS
AD  - Division of Hematology/Medical Oncology, Department of Internal Medicine, Seoul 
      National University Hospital, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Yeh, Su-Peng
AU  - Yeh SP
AD  - Division of Hematology and Oncology, Department of Medicine, China Medical 
      University Hospital, Taichung, Taiwan.
FAU - Tran, Qui
AU  - Tran Q
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Morris, Joan
AU  - Morris J
AUID- ORCID: 0000-0002-6267-7637
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Franklin, Janet
AU  - Franklin J
AD  - Amgen Inc., Thousand Oaks, California, USA.
FAU - Kiyoi, Hitoshi
AU  - Kiyoi H
AD  - Department of Hematology and Oncology, Nagoya University Graduate School of 
      Medicine, Nagoya, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02412306
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20210629
PL  - Australia
TA  - Asia Pac J Clin Oncol
JT  - Asia-Pacific journal of clinical oncology
JID - 101241430
RN  - 0 (Antibodies, Bispecific)
RN  - 0 (Antineoplastic Agents)
RN  - 4FR53SIF3A (blinatumomab)
SB  - IM
MH  - Adult
MH  - *Antibodies, Bispecific/adverse effects
MH  - *Antineoplastic Agents/therapeutic use
MH  - Humans
MH  - *Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/drug therapy
MH  - *Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy
MH  - Remission Induction
PMC - PMC9292847
OTO - NOTNLM
OT  - Asia
OT  - acute lymphoblastic leukemia (ALL)
OT  - blinatumomab
OT  - post hoc analysis
OT  - relapsed/refractory
COIS- The authors had full access to all data in the study and had final responsibility 
      for the decision to submit for publication. Yukio Kobayashi received research 
      funding from Amgen Astellas BioPharma and Pfizer; received compensation from 
      SymBio for an advisory role; and participated in a speaker's bureau for Amgen 
      Astellas BioPharma and Pfizer. Hironobu Minami received grants from Asahi-Kasei 
      Pharma, Astellas, Nippon Shinyaku, Taisho Toyama, Teijin Pharma, Yakult, CSL 
      Behring, Nippon Kayaku, and Shionogi; received grants and personal fees from 
      Bayer; received grants and personal fees from Boehringer Ingelheim, Eisai, Kyowa 
      Kirin, Eli Lilly, Merck Serono, Nippon Chemiphar, Sanofi, Takeda, and Sumitomo 
      Dainippon Pharma; received grants and personal fees, personal fees from Bristol 
      Myers Squibb; received personal fees from Celgene, Janssen, Otsuka, Shire Japan, 
      Genomic Health, AbbVie, and Kyowa; received grants and personal fees from Chugai; 
      received grants from Daiichi Sankyo; received grants and personal fees from MSD; 
      received grants and personal fees from Ono Pharmaceutical; received grants, 
      personal fees from Pfizer; received grants and personal fees from Taiho; received 
      personal fees from Novartis; and received personal fees from Nihon Medi-Physics, 
      outside the submitted work. Yoshinobu Maeda received research funding from 
      Bristol Myers Squibb and Astellas; and received honoraria from Bristol Myers 
      Squibb, Mundipharma, and Kyowa Kirin. Sung-Soo Yoon received compensation for a 
      consulting or advisory role from Janssen, Takeda, Amgen, Celgene, Novartis, 
      Astellas; received honoraria from Novartis; received research funding from Yuhan 
      Pharmaceutical, Kyowa Kirin, and Roche-Genentech. Qui Tran, Joan Morris, and 
      Janet Franklin are employees and stockholders of Amgen. Hitoshi Kiyoi received 
      research funding from FUJIFILM, Otsuka, Chugai, Kyowa Kirin, Astellas, Zenoaq 
      Kogyo, Nippon Shinyaku, Eisai, Takeda, Sumitomo Dainippon Pharma, Bristol Myers 
      Squibb, Perseus Proteomics, and Daiichi Sankyo; and received honoraria from 
      Pfizer Japan and Astellas. Hiroatsu Iida received research funding from Chugai. 
      Iekuni Oh, Toshihiro Miyamoto, Won-Sik Lee, Jun Ho Jang, and Su-Peng Yeh have 
      nothing to disclose.
EDAT- 2021/06/30 06:00
MHDA- 2022/05/25 06:00
PMCR- 2022/07/18
CRDT- 2021/06/29 17:26
PHST- 2021/03/19 00:00 [received]
PHST- 2021/04/26 00:00 [accepted]
PHST- 2021/06/30 06:00 [pubmed]
PHST- 2022/05/25 06:00 [medline]
PHST- 2021/06/29 17:26 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - AJCO13609 [pii]
AID - 10.1111/ajco.13609 [doi]
PST - ppublish
SO  - Asia Pac J Clin Oncol. 2022 Jun;18(3):311-318. doi: 10.1111/ajco.13609. Epub 2021 
      Jun 29.