Sintilimab in combination with stereotactic body radiotherapy and granulocyte-macrophage colony-stimulating factor in metastatic non-small cell lung cancer: The multicenter SWORD phase 2 trial

Jianjiao Ni, Xiaofei Wang, Lin Wu, Xinghao Ai, Qian Chu, Chengbo Han, Xiaorong Dong, Yue Zhou, Yechun Pang and Zhengfei Zhu ()
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Jianjiao Ni: Fudan University Shanghai Cancer Center
Xiaofei Wang: Duke University School of Medicine
Lin Wu: Central South University
Xinghao Ai: Shanghai Jiao Tong University
Qian Chu: Huazhong University of Science and Technology
Chengbo Han: Shengjing Hospital of China Medical University
Xiaorong Dong: Huazhong University of Science and Technology
Yue Zhou: Fudan University Shanghai Cancer Center
Yechun Pang: Fudan University Shanghai Cancer Center
Zhengfei Zhu: Fudan University Shanghai Cancer Center

Nature Communications, 2024, vol. 15, issue 1, 1-14

Abstract: Abstract This single-arm, multicenter, phase 2 trial (NCT04106180) investigated the triple combination of sintilimab (anti-PD1 antibody), stereotactic body radiotherapy (SBRT) and granulocyte-macrophage colony-stimulating factor (GM-CSF) in metastatic non-small cell lung cancer (NSCLC). With a median follow-up of 32.1 months, 18 (36.7%, 90% CI 25.3%–49.5%) of the 49 evaluable patients had an objective response, meeting the primary endpoint. Secondary endpoints included out-of-field (abscopal) response rate (ASR), progression-free survival (PFS), overall survival (OS), and treatment-related adverse events (TRAEs). The ASR was 30.6% (95% CI 18.3%–45.4%). The median PFS and OS were 5.9 (95% CI 2.5–9.3) and 18.4 (95% CI 9.7–27.1) months, respectively. Any grade and grade 3 TRAEs occurred in 44 (86.3%) and 6 (11.8%) patients, without grade 4–5 TRAEs. Moreover, in pre-specified biomarker analyses, SBRT-induced increase of follicular helper T cells (Tfh) in unirradiated tumor lesions and patient’s blood, as well as of circulating IL-21 levels, was found associated with improved prognosis. Taken together, the triple combination therapy was well tolerated with promising efficacy and Tfh may play a critical role in SBRT-triggered anti-tumor immunity in metastatic NSCLC.

Date: 2024
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DOI: 10.1038/s41467-024-51807-7

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