Sintilimab with two cycles of chemotherapy for the treatment of advanced squamous non-small cell lung cancer: a phase 2 clinical trial

Mina Zhang, Guowei Zhang, Yuanyuan Niu, Guifang Zhang, Yinghua Ji, Xiangtao Yan, Xiaojuan Zhang, Qichuan Wang, Xiaohui Jing, Junsheng Wang, Zhiyong Ma and Huijuan Wang ()
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Mina Zhang: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Guowei Zhang: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Yuanyuan Niu: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Guifang Zhang: Xinxiang Central Hospital
Yinghua Ji: The First Affiliated Hospital of Xinxiang Medical University
Xiangtao Yan: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Xiaojuan Zhang: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Qichuan Wang: The Second People’s Hospital of Nanyang
Xiaohui Jing: The First People’s Hospital of Pingdingshan
Junsheng Wang: Anyang Cancer Hospital
Zhiyong Ma: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Huijuan Wang: The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract This was a single-arm, multicenter phase 2 clinical trial (ChiCTR1900021726) involving advanced squamous non-small cell lung cancer (sq-NSCLC) patients undergoing 2 cycles of nab-paclitaxel/carboplatin and sintilimab (anti-PD-1), followed by sintilimab maintenance therapy. The median progression-free survival (PFS) was 11.4 months (95% CI: 6.7-18.1), which met the pre-specified primary endpoint. Secondary endpoints included objective response rate reaching 70.5% and a disease control rate of 93.2%, with a median duration of response of 13.6 months [95% CI: 7.0–not evaluable (NE)]. The median overall survival was 27.2 months (95% CI: 20.2–NE) with treatment-related adverse events grades ≥3 occurring in 10.9% of patients. Predefined exploratory endpoints comprised relationships between biomarkers and treatment efficacy, and the association between circulating tumor DNA (ctDNA) dynamics and PFS. Biomarker analysis revealed that the breast cancer gene 2, BMP/Retinoic Acid Inducible Neural Specific 3, F-box/WD repeat-containing protein 7, tyrosine-protein kinase KIT and retinoblastoma 1 abnormalities led to shorter PFS, while ctDNA negative at baseline or clearance at 2 cycles of treatment was associated with longer PFS (18.1 vs. 4.3 months). Taken together, sintilimab in combination with 2 cycles of nab-paclitaxel/carboplatin treatment produced encouraging PFS and better tolerability as first-line treatment for advanced sq-NSCLC.

Date: 2024
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DOI: 10.1038/s41467-024-45769-z

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