Regimen selection for combined immunotherapy in non-small cell lung cancer with PD-L1 < 1%: a multicenter, retrospective study from Japan (SPIRAL-LT1)
Abstract
This multicenter retrospective study at 22 centers in Japan using electronic medical record data aimed to compare the effectiveness and safety of CTLA-4 regimens (ipilimumab plus nivolumab with or without chemotherapy) versus non-CTLA-4 regimens (pembrolizumab or atezolizumab plus chemotherapy) as first-line treatment for patients with advanced or recurrent NSCLC expressing PD-L1 < 1%. Dual primary endpoints were PFS and OS after propensity score matching (PSM) incorporating age, gender, PS, stage, histology, driver mutations, smoking, liver metastasis, and brain metastasis. Safety was assessed by the incidence and onset timing of ≥ grade 3 drug-related AEs. A total of 124 patients each were analyzed for both regimens. PFS and OS did not differ between CTLA-4 and non-CTLA-4 regimens, and exploratory subgroup analyses showed no substantial differences in treatment effect across patient characteristics. The CTLA-4 regimen had a higher incidence of ≥ grade 3 irAEs, particularly hepatic and gastrointestinal disease, and a lower incidence of ≥ grade 3 chemo-AEs. Onset of grade ≥ 3 irAEs also differed between regimens, and late-onset events with CTLA-4 regimens showed longer OS. In conclusion, while first-line CTLA-4 and non-CTLA-4 regimens showed comparable effectiveness in patients with NSCLC expressing PD-L1 < 1%, distinct toxicity profiles were observed, suggesting careful consideration of safety profiles is warranted.
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BibTeX
@article{murata2026regimen,
title = {{Regimen selection for combined immunotherapy in non-small cell lung cancer with PD-L1 < 1%: a multicenter, retrospective study from Japan (SPIRAL-LT1)}},
author = {Daiki Murata and Koichi Azuma and Kenta Murotani and Kazuhiro Ito and Takashi Nomizo and Kazuhiko Yamada and Tatsuya Imabayashi and Kentaro Iwanaga and Kenji Chibana and Takayo Ota and Yuuya Nishii and Akira Nakao and Asuka Okada and Kosuke Hamai and Keiko Tanimura and Kohei Yoshimine and Yosuke Tamura and Ryuichiro Takaki and Yasuhiro Goto and Makoto Hibino and Tomohiro Oba and Toshiyuki Sumi and Hiroyasu Kaneda and Naoya Nishioka and Tadaaki Yamada and Koichi Takayama},
journal = {Scientific Reports},
year = {2026},
month = oct,
doi = {10.1038/s41598-026-74087-1},
url = {https://www.nature.com/articles/s41598-026-74087-1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Regimen selection for combined immunotherapy in non-small cell lung cancer with PD-L1 < 1%: a multicenter, retrospective study from Japan (SPIRAL-LT1)
AU - Daiki Murata
AU - Koichi Azuma
AU - Kenta Murotani
AU - Kazuhiro Ito
AU - Takashi Nomizo
AU - Kazuhiko Yamada
AU - Tatsuya Imabayashi
AU - Kentaro Iwanaga
AU - Kenji Chibana
AU - Takayo Ota
AU - Yuuya Nishii
AU - Akira Nakao
AU - Asuka Okada
AU - Kosuke Hamai
AU - Keiko Tanimura
AU - Kohei Yoshimine
AU - Yosuke Tamura
AU - Ryuichiro Takaki
AU - Yasuhiro Goto
AU - Makoto Hibino
AU - Tomohiro Oba
AU - Toshiyuki Sumi
AU - Hiroyasu Kaneda
AU - Naoya Nishioka
AU - Tadaaki Yamada
AU - Koichi Takayama
PY - 2026
DA - 2026/10/16
JO - Scientific Reports
DO - 10.1038/s41598-026-74087-1
UR - https://www.nature.com/articles/s41598-026-74087-1
AB - This multicenter retrospective study at 22 centers in Japan using electronic medical record data aimed to compare the effectiveness and safety of CTLA-4 regimens (ipilimumab plus nivolumab with or without chemotherapy) versus non-CTLA-4 regimens (pembrolizumab or atezolizumab plus chemotherapy) as first-line treatment for patients with advanced or recurrent NSCLC expressing PD-L1 < 1%. Dual primary endpoints were PFS and OS after propensity score matching (PSM) incorporating age, gender, PS, stage, histology, driver mutations, smoking, liver metastasis, and brain metastasis. Safety was assessed by the incidence and onset timing of ≥ grade 3 drug-related AEs. A total of 124 patients each were analyzed for both regimens. PFS and OS did not differ between CTLA-4 and non-CTLA-4 regimens, and exploratory subgroup analyses showed no substantial differences in treatment effect across patient characteristics. The CTLA-4 regimen had a higher incidence of ≥ grade 3 irAEs, particularly hepatic and gastrointestinal disease, and a lower incidence of ≥ grade 3 chemo-AEs. Onset of grade ≥ 3 irAEs also differed between regimens, and late-onset events with CTLA-4 regimens showed longer OS. In conclusion, while first-line CTLA-4 and non-CTLA-4 regimens showed comparable effectiveness in patients with NSCLC expressing PD-L1 < 1%, distinct toxicity profiles were observed, suggesting careful consideration of safety profiles is warranted.
SN - 2045-2322
ER -