Regimen selection for combined immunotherapy in non-small cell lung cancer with PD-L1 < 1%: a multicenter, retrospective study from Japan (SPIRAL-LT1)
Year: 2026
Type: article
Study design: Observational Study
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.
Source: Scientific Reports
Authors: Daiki Murata, Koichi Azuma, Kenta Murotani, Kazuhiro Ito, Takashi Nomizo, Kazuhiko Yamada, Tatsuya Imabayashi, Kentaro Iwanaga, Kenji Chibana, Takayo Ota, Yuuya Nishii, Akira Nakao, Asuka Okada, Kosuke Hamai, Keiko Tanimura, Kohei Yoshimine, Yosuke Tamura, Ryuichiro Takaki, Yasuhiro Goto, Makoto Hibino, Tomohiro Oba, Toshiyuki Sumi, Hiroyasu Kaneda, Naoya Nishioka, Tadaaki Yamada, Koichi Takayama
Institutions: Kurume University, Kyoto Yamashiro General Medical Center, Kyoto University, Shin Koga Hospital, Kyoto first Red Cross hospital, Saga-Ken Medical Centre Koseikan, National Hospital Organization, National Hospital Organization Okinawa Hospital, Izumi City General Hospital, National Kyushu Medical Center, Fukuoka University Hospital, Saiseikai Suita Hospital, Onomichi General Hospital, Fukuchiyama City Hospital, Aso Iizuka Hospital, Osaka Medical and Pharmaceutical University, Osaka Medical and Pharmaceutical University Hospital, Oita Prefectural Hospital, Fujita Health University, Shonan Fujisawa Tokusyukai Hospital, Saitama Red Cross Hospital, Hakodate Goryoukaku Hospital, Osaka Metropolitan University, Kyoto Prefectural University of Medicine
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,690
OpenAlex ID: W7222563293
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