Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1–Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study
In this phase II study, we examined the predictive utility of the TIL biomarker for nivolumab monotherapy. Although the positivity of the TIL biomarker was limited, the promising efficacy and safety profile in the TIL biomarker-positive patients may suggest the potential utility of the TIL biomarker.
Authors
- Kyoichi Okishio (ORCID: https://orcid.org/0000-0002-6348-1302)
- Hiroki Izumi (ORCID: https://orcid.org/0000-0002-9566-4859)
- Kohei Shitara (ORCID: https://orcid.org/0000-0001-5196-3630)
- Hisashi Hosaka
- Kunihiro Tsuji (ORCID: https://orcid.org/0000-0001-7463-7272)
- Yukiya Narita (ORCID: https://orcid.org/0000-0002-8018-0077)
- Motohiro Tamiya (ORCID: https://orcid.org/0000-0001-6529-3092)
- Hiroki Hara (ORCID: https://orcid.org/0000-0003-3881-9815)
- Nobuhiko Seki (ORCID: https://orcid.org/0000-0002-6562-1137)
- Akihito Tsuji (ORCID: https://orcid.org/0000-0003-4034-1945)
- Yasunori Ushida
- Toshifumi Yamaguchi (ORCID: https://orcid.org/0000-0003-1399-1918)
- Hideaki Suna (ORCID: https://orcid.org/0000-0001-9202-316X)
- Kensei Yamaguchi (ORCID: https://orcid.org/0000-0001-6887-5709)
- Katsunori Shinozaki (ORCID: https://orcid.org/0000-0003-0596-3423)
- Hiroshi Tanaka (ORCID: https://orcid.org/0000-0002-8003-7326)
- Yosuke Tamura (ORCID: https://orcid.org/0009-0000-0513-2860)
- Naohiro Watanabe
- Takeshi Shiraishi (ORCID: https://orcid.org/0000-0001-9558-3576)
Institutions
- Kagawa University (JP)
- Osaka Medical and Pharmaceutical University (JP)
- Niigata Cancer Center Hospital (JP)
- Teikyo University Hospital (JP)
- Osaka International Cancer Institute (JP)
- Hiroshima Prefectural Hospital (JP)
- Ono Pharmaceutical (Japan) (JP)
- Matsuyama Red Cross Hospital (JP)
- Ishikawa Prefectural Central Hospital (JP)
- Saitama Cancer Center (JP)
- Gunma Prefectural Cardiovascular Center (JP)
- Aichi Cancer Center (JP)
- Tohoku Medical and Pharmaceutical University Hospital (JP)
- National Cancer Center Hospital East (JP)
- Gunma Children's Medical Center (JP)
- Osaka International Cancer Institute (JP)
- NHO Kinki Chuo Chest Medical Center (JP)
- Japanese Foundation For Cancer Research (JP)
- Teikyo University (JP)
- Osaka University of Pharmaceutical Sciences (JP)
Publication Details
- Journal
- Cancer Research Communications
- Published
- 2025-09-25
- DOI
- https://doi.org/10.1158/2767-9764.crc-25-0169
- Citations
- 2
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 2.09
Funders
- Taiho Pharmaceutical
- Astellas Pharma
- Ono Pharmaceutical
- Chugai Pharmaceutical
- Daiichi Sankyo Europe