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Peer-reviewedCC BY-NC-NDInternal Medicine

A Retrospective Study of the Efficacy and Safety of Epcoritamab in Real-world Clinical Practice: An Analysis of 19 Cases from a Single Institution

7 more authors

Abstract

Objective This study evaluated the efficacy and safety of epcoritamab in real-world clinical practice. Methods Data of 19 patients who received epcoritamab at Saitama Cancer Center were retrospectively analyzed. Results The median follow-up duration was 5.6 months. The overall response rate (ORR) was 73.7%, with a complete response (CR) rate of 47.4%. The ORR in patients with prior exposure to bendamustine was 64.3% (CR rate, 50%), and that of bendamustine-naïve was 100% (CR rate, 40%). The ORR in patients with a bendamustine-free period of ≤6 months was 42.9% (CR rate, 28.6%), while that of patients with a bendamustine-free period of >6 months was 85.7% (CR rate, 71.4%). The median progression-free survival (PFS) and overall survival (OS) have not yet been determined, but the values prior to exposure to bendamustine were 6.6 and 7.6 months, respectively. A comparison between the prior bendamustine exposure and naïve groups showed no significant differences in the PFS and OS. In patients with lactate dehydrogenase (LDH) levels of ≤303 U/L at the start of epcoritamab, the median PFS and OS were not yet reached, while in those with LDH levels of >303 U/L, the median PFS and OS were 2.3 and 3.0 months, respectively. Treatment-emergent adverse events (TEAEs) of grade ≥3 severity occurred in 18 of the 19 patients (94.7%), and in 2 of the 19 patients (10.5%), the emergence of TEAEs necessitated treatment discontinuation. Cytomegalovirus (CMV) reactivation occurred in 11 patients (57.9%). Conclusion Careful attention should be paid to aggressive cases and those with CMV reactivation.

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BibTeX
@article{sekiguchi2026retrospective,
  title = {{A Retrospective Study of the Efficacy and Safety of Epcoritamab in Real-world Clinical Practice: An Analysis of 19 Cases from a Single Institution}},
  author = {Yasunobu Sekiguchi and Shizuka Hamano and Kosuke Arai and Hiroki Tsutsumi and Masahisa Kudo and Nobuo Maseki and Yoshie Iizaki and Machiko Kawamura and Kazuhiko Kobayashi and Yu Nishimura and Hiroaki Kanda and Daisuke Takei and Tomoya Abe and Makoto Hanai and Sayaka Endo and Yu Kakusaka and Toshiaki Nakayama and Yasumasa Shimano and Hirofumi Kobayashi},
  journal = {Internal Medicine},
  year = {2026},
  month = aug,
  doi = {10.2169/internalmedicine.6396-25},
  url = {https://www.jstage.jst.go.jp/article/internalmedicine/65/15/65_6396-25/_article},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - A Retrospective Study of the Efficacy and Safety of Epcoritamab in Real-world Clinical Practice: An Analysis of 19 Cases from a Single Institution
AU  - Yasunobu Sekiguchi
AU  - Shizuka Hamano
AU  - Kosuke Arai
AU  - Hiroki Tsutsumi
AU  - Masahisa Kudo
AU  - Nobuo Maseki
AU  - Yoshie Iizaki
AU  - Machiko Kawamura
AU  - Kazuhiko Kobayashi
AU  - Yu Nishimura
AU  - Hiroaki Kanda
AU  - Daisuke Takei
AU  - Tomoya Abe
AU  - Makoto Hanai
AU  - Sayaka Endo
AU  - Yu Kakusaka
AU  - Toshiaki Nakayama
AU  - Yasumasa Shimano
AU  - Hirofumi Kobayashi
PY  - 2026
DA  - 2026/08/01
JO  - Internal Medicine
DO  - 10.2169/internalmedicine.6396-25
UR  - https://www.jstage.jst.go.jp/article/internalmedicine/65/15/65_6396-25/_article
AB  - Objective This study evaluated the efficacy and safety of epcoritamab in real-world clinical practice. Methods Data of 19 patients who received epcoritamab at Saitama Cancer Center were retrospectively analyzed. Results The median follow-up duration was 5.6 months. The overall response rate (ORR) was 73.7%, with a complete response (CR) rate of 47.4%. The ORR in patients with prior exposure to bendamustine was 64.3% (CR rate, 50%), and that of bendamustine-naïve was 100% (CR rate, 40%). The ORR in patients with a bendamustine-free period of ≤6 months was 42.9% (CR rate, 28.6%), while that of patients with a bendamustine-free period of >6 months was 85.7% (CR rate, 71.4%). The median progression-free survival (PFS) and overall survival (OS) have not yet been determined, but the values prior to exposure to bendamustine were 6.6 and 7.6 months, respectively. A comparison between the prior bendamustine exposure and naïve groups showed no significant differences in the PFS and OS. In patients with lactate dehydrogenase (LDH) levels of ≤303 U/L at the start of epcoritamab, the median PFS and OS were not yet reached, while in those with LDH levels of >303 U/L, the median PFS and OS were 2.3 and 3.0 months, respectively. Treatment-emergent adverse events (TEAEs) of grade ≥3 severity occurred in 18 of the 19 patients (94.7%), and in 2 of the 19 patients (10.5%), the emergence of TEAEs necessitated treatment discontinuation. Cytomegalovirus (CMV) reactivation occurred in 11 patients (57.9%). Conclusion Careful attention should be paid to aggressive cases and those with CMV reactivation.
SN  - 1349-7235
SN  - 0918-2918
ER  -