NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study

Nakai, Shigeto; Makino, Tomoki; Momose, Kota; Yamashita, Kotaro; Tanaka, Koji; Miyata, Hiroshi; Yamamoto, Sachiko; Motoori, Masaaki; Kimura, Yutaka; Takeoka, Tomohira; Hirao, Motohiro; Matsuyama, Jin; Akamaru, Yusuke; Kurokawa, Yukinori; Morii, Eiichi; Eguchi, Hidetoshi; Doki, Yuichiro

doi:https://doi.org/10.1007/s00262-026-04415-x

NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study

Nakai, Shigeto; Makino, Tomoki; Momose, Kota et al.

Cancer Immunology, Immunotherapy, 2026, 75, 182

Number of Access:407（2026-09-29 08:33 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/106060

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Title	NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study
Creator	NRID 1000040912027 1000040912027 ORCID 0009-0002-8713-9365 0009-0002-8713-9365 Scopus Author ID 57201910767 57201910767 CreatorName Nakai, Shigeto
	NRID 1000080528620 1000080528620 ORCID 0000-0001-7918-4217 0000-0001-7918-4217 researchmap permalink _-_-_- _-_-_- Scopus Author ID 56339970700 56339970700 CreatorName Makino, Tomoki
	NRID 1000050749752 1000050749752 ORCID 0009-0004-2623-2122 0009-0004-2623-2122 researchmap permalink kom2005 kom2005 Scopus Author ID 59711925000 59711925000 CreatorName Momose, Kota
	NRID 1000020747159 1000020747159 researchmap permalink k-yamashita k-yamashita Scopus Author ID 57191498316 57191498316 CreatorName Yamashita, Kotaro
	NRID 1000070621019 1000070621019 ORCID 0000-0001-5178-9388 0000-0001-5178-9388 researchmap permalink koji_tanaka koji_tanaka Scopus Author ID 55628548952 55628548952 CreatorName Tanaka, Koji
	NRID 1000080362713 1000080362713 CreatorName Miyata, Hiroshi
	CreatorName Yamamoto, Sachiko
	CreatorName Motoori, Masaaki
	NRID 1000080716994 1000080716994 CreatorName Kimura, Yutaka
	CreatorName Takeoka, Tomohira
	CreatorName Hirao, Motohiro
	CreatorName Matsuyama, Jin
	CreatorName Akamaru, Yusuke
	NRID 1000010470197 1000010470197 ORCID 0000-0002-2883-0132 0000-0002-2883-0132 researchmap permalink krkw krkw Scopus Author ID 7202562410 7202562410 CreatorName Kurokawa, Yukinori
	NRID 1000010283772 1000010283772 ORCID 0000-0001-8490-3650 0000-0001-8490-3650 researchmap permalink read0046454 read0046454 Scopus Author ID 7003914326 7003914326 CreatorName Morii, Eiichi
	NRID 1000090542118 1000090542118 ORCID 0000-0002-2318-1129 0000-0002-2318-1129 researchmap permalink abcdabcdabcd abcdabcdabcd Scopus Author ID 7101627772 7101627772 CreatorName Eguchi, Hidetoshi
	NRID 1000020291445 1000020291445 researchmap permalink ydoki3251 ydoki3251 Scopus Author ID 7006390687 7006390687 CreatorName Doki, Yuichiro
Subject	Anti-PD-1 antibody
	Biomarker
	Esophageal squamous cell carcinoma
	NY-ESO-1
	PD-L1
Description	Nakai S., Makino T., Momose K., et al. NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study. Cancer Immunology, Immunotherapy 75, 182 (2026); https://doi.org/10.1007/s00262-026-04415-x.
Abstract	Background: Programmed cell death protein-1 (PD-1) blockade improves survival in esophageal squamous cell carcinoma (ESCC), although only a subset of patients respond. We aimed to identify tumor-related biomarkers associated with response and outcome in patients with unresectable or recurrent ESCC. Methods: This multicenter retrospective study included 250 patients with unresectable or recurrent ESCC who received nivolumab as second- or later-line therapy. Pretreatment tumor specimens were evaluated by immunohistochemistry for p53, NY-ESO-1, MLH1, and programmed death-ligand 1 (PD-L1). PD-L1 expression was assessed using both tumor proportion score (TPS) and combined positive score (CPS) by using automated digital image analysis. Associations with objective response, progression-free survival (PFS), and overall survival (OS) were analyzed. Results: NY-ESO-1 expression was significantly associated with response to nivolumab (28.6% vs. 11.1%, P = 0.005) and remained independently associated with response in multivariate analysis (OR 3.32, 95% CI 1.49–7.28, P = 0.0027). PD-L1 expression was also associated with response according to both CPS and TPS. Patients with CPS ≥ 10% showed higher response rates than those with CPS < 10% (24.1% vs. 10.2%, P = 0.003), as well as longer median PFS (2.6 vs. 2.0 months, P = 0.0173) and OS (12.3 vs. 10.4 months, P = 0.0479). In contrast, p53 expression showed no significant association with response or survival, and MLH1 loss was rare. Conclusions: NY-ESO-1 expression was associated with response to nivolumab, while PD-L1 expression, particularly CPS, may provide clinically relevant prognostic information. Integrated assessment of tumor-related biomarkers and the host immune microenvironment may further improve patient stratification in ESCC.
Publisher	Springer Science and Business Media Deutschland GmbH
Source Title	Cancer Immunology, Immunotherapy
Volume (Issue)	75
Page	182
Date of Issued	2026-05-12
Language	English
Handle URL	https://hdl.handle.net/11094/106060
PISSN	03407004
eISSN	14320851
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1007/s00262-026-04415-x
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Cancer Immunology, Immunotherapy. 2026, 75, p. 182
DC.title	NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study
DC.creator	Nakai, Shigeto
	Makino, Tomoki
	Momose, Kota
	Yamashita, Kotaro
	Tanaka, Koji
	Miyata, Hiroshi
	Yamamoto, Sachiko
	Motoori, Masaaki
	Kimura, Yutaka
	Takeoka, Tomohira
	Hirao, Motohiro
	Matsuyama, Jin
	Akamaru, Yusuke
	Kurokawa, Yukinori
	Morii, Eiichi
	Eguchi, Hidetoshi
	Doki, Yuichiro
DC.publisher	Springer Science and Business Media Deutschland GmbH
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2026-05-12
DC.identifier	https://doi.org/10.1007/s00262-026-04415-x
DC.subject	Anti-PD-1 antibody
	Biomarker
	Esophageal squamous cell carcinoma
	NY-ESO-1
	PD-L1
DC.description	Nakai S., Makino T., Momose K., et al. NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study. Cancer Immunology, Immunotherapy 75, 182 (2026); https://doi.org/10.1007/s00262-026-04415-x.
DCTERMS.abstract	Background: Programmed cell death protein-1 (PD-1) blockade improves survival in esophageal squamous cell carcinoma (ESCC), although only a subset of patients respond. We aimed to identify tumor-related biomarkers associated with response and outcome in patients with unresectable or recurrent ESCC. Methods: This multicenter retrospective study included 250 patients with unresectable or recurrent ESCC who received nivolumab as second- or later-line therapy. Pretreatment tumor specimens were evaluated by immunohistochemistry for p53, NY-ESO-1, MLH1, and programmed death-ligand 1 (PD-L1). PD-L1 expression was assessed using both tumor proportion score (TPS) and combined positive score (CPS) by using automated digital image analysis. Associations with objective response, progression-free survival (PFS), and overall survival (OS) were analyzed. Results: NY-ESO-1 expression was significantly associated with response to nivolumab (28.6% vs. 11.1%, P = 0.005) and remained independently associated with response in multivariate analysis (OR 3.32, 95% CI 1.49–7.28, P = 0.0027). PD-L1 expression was also associated with response according to both CPS and TPS. Patients with CPS ≥ 10% showed higher response rates than those with CPS < 10% (24.1% vs. 10.2%, P = 0.003), as well as longer median PFS (2.6 vs. 2.0 months, P = 0.0173) and OS (12.3 vs. 10.4 months, P = 0.0479). In contrast, p53 expression showed no significant association with response or survival, and MLH1 loss was rare. Conclusions: NY-ESO-1 expression was associated with response to nivolumab, while PD-L1 expression, particularly CPS, may provide clinically relevant prognostic information. Integrated assessment of tumor-related biomarkers and the host immune microenvironment may further improve patient stratification in ESCC.
DC.rights	This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
DC.format	106060
citation_title	NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study
citation_author	Nakai, Shigeto
	Makino, Tomoki
	Momose, Kota
	Yamashita, Kotaro
	Tanaka, Koji
	Miyata, Hiroshi
	Yamamoto, Sachiko
	Motoori, Masaaki
	Kimura, Yutaka
	Takeoka, Tomohira
	Hirao, Motohiro
	Matsuyama, Jin
	Akamaru, Yusuke
	Kurokawa, Yukinori
	Morii, Eiichi
	Eguchi, Hidetoshi
	Doki, Yuichiro
citation_publisher	Springer Science and Business Media Deutschland GmbH
citation_language	English
citation_date	2026-05-12
citation_journal_title	Cancer Immunology, Immunotherapy
citation_volume	75
citation_firstpage	182
citation_doi	https://doi.org/10.1007/s00262-026-04415-x
citation_public_url	https://hdl.handle.net/11094/106060

NY-ESO-1 and PD-L1 as biomarkers associated with nivolumab response and outcome in unresectable or recurrent esophageal squamous cell carcinoma: a multicenter biomarker study

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