PMID- 34609773
OWN - NLM
STAT- MEDLINE
DCOM- 20211209
LR  - 20211218
IS  - 1349-7006 (Electronic)
IS  - 1347-9032 (Print)
IS  - 1347-9032 (Linking)
VI  - 112
IP  - 12
DP  - 2021 Dec
TI  - Safety and efficacy of depatuxizumab mafodotin in Japanese patients with 
      malignant glioma: A nonrandomized, phase 1/2 trial.
PG  - 5020-5033
LID - 10.1111/cas.15153 [doi]
AB  - INTELLANCE-J was a phase 1/2 study of a potent antibody-drug conjugate targeting 
      epidermal growth factor receptor (EGFR), depatuxizumab mafodotin (Depatux-M), as 
      a second- or first-line therapy, alone or combined with chemotherapy or 
      chemoradiotherapy in 53 Japanese patients with World Health Organization (WHO) 
      grade III/IV glioma. In second-line arms, patients with EGFR-amplified recurrent 
      WHO grade III/IV glioma received Depatux-M plus chemotherapy (temozolomide) or 
      Depatux-M alone regardless of EGFR status. In first-line arms, patients with 
      newly diagnosed WHO grade III/IV glioma received Depatux-M plus 
      chemoradiotherapy. The study was halted following lack of survival benefit with 
      first-line Depatux-M in the global trial INTELLANCE-1. The primary endpoint was 
      6-month progression-free survival (PFS) in patients with EGFR-amplified tumors 
      receiving second-line Depatux-M plus chemotherapy. Common nonocular 
      treatment-emergent adverse events (TEAEs) with both second-line and first-line 
      Depatux-M included lymphopenia (42%, 33%, respectively), thrombocytopenia (39%, 
      47%), alanine aminotransferase increase (29%, 47%), and aspartate 
      aminotransferase increase (24%, 60%); incidence of grade >/=3 TEAEs was 66% and 
      53%, respectively. Ocular side effects (OSEs) occurred in 93% of patients 
      receiving second-line Depatux-M plus chemotherapy and all patients receiving 
      second-line Depatux-M alone or first-line Depatux-M plus chemoradiotherapy. Most 
      OSEs were manageable with dose modifications and concomitant medications. The 
      6-month PFS estimate was 25.6% (95% confidence interval [CI] 11.4-42.6), and 
      median PFS was 2.1 months (95% CI 1.9-3.9) with second-line Depatux-M plus 
      chemotherapy in the EGFR-amplified subgroup. This study showed acceptable safety 
      profile of Depatux-M alone or plus chemotherapy/chemoradiotherapy in Japanese 
      patients with WHO grade III/IV glioma. The study was registered at 
      ClinicalTrials.gov (NCT02590263).
CI  - (c) 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd 
      on behalf of Japanese Cancer Association.
FAU - Narita, Yoshitaka
AU  - Narita Y
AUID- ORCID: 0000-0003-4303-6006
AD  - Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, 
      Tokyo, Japan.
FAU - Muragaki, Yoshihiro
AU  - Muragaki Y
AD  - Department of Neurosurgery, Tokyo Women's Medical University Hospital, Tokyo, 
      Japan.
FAU - Kagawa, Naoki
AU  - Kagawa N
AD  - Department of Neurosurgery, Osaka University Hospital, Osaka, Japan.
FAU - Asai, Katsunori
AU  - Asai K
AD  - Department of Neurosurgery, Osaka International Cancer Institute, Osaka, Japan.
FAU - Nagane, Motoo
AU  - Nagane M
AUID- ORCID: 0000-0002-0018-1652
AD  - Faculty of Medicine, Department of Neurosurgery, Kyorin University, Tokyo, Japan.
FAU - Matsuda, Masahide
AU  - Matsuda M
AUID- ORCID: 0000-0003-2857-0374
AD  - Department of Neurosurgery, University of Tsukuba, Ibaraki, Japan.
FAU - Ueki, Keisuke
AU  - Ueki K
AD  - Department of Neurosurgery, Dokkyo Medical University Hospital, Tochigi, Japan.
FAU - Kuroda, Junichiro
AU  - Kuroda J
AD  - Department of Neurosurgery, Kumamoto University Hospital, Kumamoto, Japan.
FAU - Date, Isao
AU  - Date I
AD  - Department of Neurosurgery, Okayama University Hospital, Okayama, Japan.
FAU - Kobayashi, Hiroyuki
AU  - Kobayashi H
AD  - Department of Neurosurgery, Hokkaido University Hospital, Hokkaido, Japan.
FAU - Kumabe, Toshihiro
AU  - Kumabe T
AD  - Department of Neurosurgery, Kitasato University Hospital, Kanagawa, Japan.
FAU - Beppu, Takaaki
AU  - Beppu T
AD  - Department of Neurosurgery, Iwate Medical University Hospital, Iwate, Japan.
FAU - Kanamori, Masayuki
AU  - Kanamori M
AD  - Department of Neurosurgery, Tohoku University Hospital, Miyagi, Japan.
FAU - Kasai, Shota
AU  - Kasai S
AD  - AbbVie GK., Tokyo, Japan.
FAU - Nishimura, Yasuko
AU  - Nishimura Y
AD  - AbbVie GK., Tokyo, Japan.
FAU - Xiong, Hao
AU  - Xiong H
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Ocampo, Christopher
AU  - Ocampo C
AD  - AbbVie Inc., North Chicago, Illinois, USA.
FAU - Yamada, Masakazu
AU  - Yamada M
AD  - Department of Ophthalmology, Kyorin University Hospital, Tokyo, Japan.
FAU - Mishima, Kazuhiko
AU  - Mishima K
AD  - Department of Neuro-Oncology/Neurosurgery, International Medical Center, Saitama 
      Medical University, Saitama, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02590263
GR  - AbbVie/
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
DEP - 20211030
PL  - England
TA  - Cancer Sci
JT  - Cancer science
JID - 101168776
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
RN  - F3R7A4P04N (depatuxizumab mafodotin)
RN  - YF1K15M17Y (Temozolomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Brain Neoplasms/*drug therapy/genetics/pathology/radiotherapy
MH  - Chemoradiotherapy
MH  - Drug Therapy
MH  - ErbB Receptors/genetics
MH  - Female
MH  - Gene Amplification
MH  - Glioma/*drug therapy/genetics/pathology/radiotherapy
MH  - Humans
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Survival Analysis
MH  - Temozolomide/*administration & dosage/adverse effects
MH  - Treatment Outcome
PMC - PMC8645742
OTO - NOTNLM
OT  - Anti-epidermal growth factor receptor therapy
OT  - depatuxizumab mafodotin
OT  - malignant glioma
OT  - recurrent glioblastoma
OT  - temozolomide
COIS- Yoshitaka Narita: research funding grants: AbbVie, Dainippon-Sumitomo, Eisai, Ono 
      Pharmaceutical Co., and Stella-pharma; personal fees: Chugai Pharmaceutical Co. 
      and Daiichi-Sankyo. Motoo Nagane: grants or contracts (personal and/or 
      institution): AbbVie, Astellas, Bayer, Chugai, Daiichi-Sankyo, Eisai, MSD, Nippon 
      Kayaku, Ono Pharma, Otsuka, Pfizer, Shionogi, Teijin, and Tsumura; honoraria: 
      AbbVie, Chugai, Daiichi-Sankyo, Eisai, MSD, Nippon Kayaku, Novocure, Ono Pharma, 
      and Sumitomo-Dainippon; support for meetings and/or travel: BMS, Nippon Kayaku, 
      Ono Pharma, and RIEMSER; advisory board: AbbVie, BMS, Daiichi-Sankyo; Ono Pharma, 
      RIEMSER, and Sumitomo-Dainippon. Shota Kasai, Yasuko Nishimura, Hao Xiong, and 
      Christopher Ocampo: AbbVie employees and may hold stock or options. Yoshihiro 
      Muragaki: consulting or advisory: AbbVie, Ono Pharmaceutical, and Daiichi Sankyo; 
      speakers' bureau: MSD, Daiichi Sankyo, Chugai Pharma, Otsuka, Eisai, Novartis, 
      Hitachi Chemical, and Bristol-Myers Squibb Japan; research funding (institution): 
      MSD, Daiichi Sankyo, Chugai Pharma, Otsuka, Eisai, and Hitachi Chemical. Keisuke 
      Ueki: grants or contracts (personal and/or institution): Otsuka Pharma, Eisai, 
      Torii Pharma, Elei Lilly, Taihho, MSD, Daiichi-Sankyo, Pfizer, Kyowa-Kirin, Ono 
      Pharma, Astellas, Teijin, EA Pharma, Shionogi, Nippon Kayaku, Yakult, Mochida, 
      and Tanabe-Mitsubishi; honoraria: Chugai Pharmaceutical, Eisai, Daiichi Sankyo, 
      and Otsuka Pharmaceutical. Naoki Kagawa, Katsunori Asai, Masahide Matsuda, 
      Junichiro Kuroda, Isao Date, Hiroyuki Kobayashi, Toshihiro Kumabe, Takaaki Beppu, 
      Masayuki Kanamori, and Masakazu Yamada: nothing to disclose. Kazuhiko Mishima: 
      research funding and honoraria: AbbVie, Daiichi Sankyo, Eisai, Medical U and A, 
      MSD, Nihon Medi-Physics, Ono Pharmaceutical Co, Ltd, Otsuka, and Teijin Pharma.
EDAT- 2021/10/06 06:00
MHDA- 2021/12/15 06:00
PMCR- 2021/12/01
CRDT- 2021/10/05 12:34
PHST- 2021/09/24 00:00 [revised]
PHST- 2021/06/11 00:00 [received]
PHST- 2021/09/25 00:00 [accepted]
PHST- 2021/10/06 06:00 [pubmed]
PHST- 2021/12/15 06:00 [medline]
PHST- 2021/10/05 12:34 [entrez]
PHST- 2021/12/01 00:00 [pmc-release]
AID - CAS15153 [pii]
AID - 10.1111/cas.15153 [doi]
PST - ppublish
SO  - Cancer Sci. 2021 Dec;112(12):5020-5033. doi: 10.1111/cas.15153. Epub 2021 Oct 30.