Cited by 227Cancer Immunotherapy and BiomarkersLung Cancer Treatments and MutationsLung Cancer Diagnosis and Treatment

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Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC

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Chu, Tianqing, Zhong, Runbo, Zhong, Hua, Zhang, Bo, Zhang, Wei, Shi, Chunlei, Qian, Jialin, Zhang, Yanwei, Chang, Qing, Zhang, Xueyan, Dong, Yu, Teng, Jiajun, Gao, Zhiqiang, Qiang, Huiping, Nie, Wei, Zhao, Yiming, Han, Yuchen, Chen, Ya, Han, Baohui·2021·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2020.11.026

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Abstract

Introduction Although the interaction between tumor immune microenvironment and angiogenesis has been well established, evidence supporting the chemo-free combination of immune checkpoint inhibitors plus antiangiogenic tyrosine kinase inhibitors in treatment-naive patients with advanced NSCLC is insufficient. This report provides the efficacy and safety of sintilimab combined with anlotinib as first-line therapy for advanced NSCLC from a phase 1b trial (NCT03628521).Methods Eligible patients who were treatment-naive and had unresectable stage IIIB/C or IV NSCLC without EGFR/ALK/ROS1 mutations received sintilimab (200 mg, day 1) and anlotinib (12 mg, day 1-14) every 3 weeks till disease progression or unacceptable toxicity. Baseline programmed death-ligand 1 expression and tumor mutation burden status was assessed in all patients. The primary end points were objective response rate and safety.Results A total of 22 patients received sintilimab and anlotinib. Median follow-up was 15.8 months (range: 8.3-19.3). Sixteen patients achieved confirmed partial response with an objective response rate of 72.7% (95% confidence interval [CI]: 49.8%-89.3%) and disease control rate of 100% (95% CI: 84.6%-100%). Median progression-free survival was 15 months (95% CI: 8.3 m, not reached), and the 12-month progression-free survival rate was 71.4% (95% CI: 47.2%-86.0%). The incidence rate of grade 3 or higher treatment-related adverse events was 54.5%, and grade 3 hypertension was predominant (two of 22, 9.1%). No grade 4 treatment-related adverse events were observed, and one case of grade 5 immune-related pneumonitis occurred.Conclusions To the best of our knowledge, this is the first study that assessed an anti-programmed cell death protein 1 antibody combined with a multitarget antiangiogenic tyrosine kinase inhibitor in the frontline setting for patients with NSCLC. In view of its encouraging efficacy, durability, and safety profile, sintilimab plus anlotinib represents a novel chemotherapy-free regimen in this patient population.

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Authors: Chu, T., Zhong, R., Zhong, H., Zhang, B., Zhang, W., Shi, C., Qian, J., Zhang, Y., Chang, Q., Zhang, X., Dong, Y., Teng, J., Gao, Z., Qiang, H., Nie, W., Zhao, Y., Han, Y., Chen, Y., & Han, B.
Affiliations: Shanghai Jiao Tong University (CN)
Corresponding author: Han, Baohui
ORCID: Chu, Tianqing
Zhong, Runbo
Zhong, Hua
Zhang, Bo
Zhang, Wei
Shi, Chunlei
Qian, Jialin
Zhang, Yanwei
Chang, Qing
Zhang, Xueyan
Dong, Yu
Teng, Jiajun
Gao, Zhiqiang
Nie, Wei
Zhao, Yiming
Han, Yuchen
Chen, Ya
Han, Baohui
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2021-04
Volume: 16
Issue: 4
Pages: 643-652
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2020.11.026
OpenAlex: W3126928179
Cited by: 227
References: 37
Citations by year: 2026: 11 · 2025: 35 · 2024: 56 · 2023: 53 · 2022: 54 · 2021: 17
FWCI: 16.38
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: Science and Technology Commission of Shanghai Municipality (18411968500)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: sintilimab, anlotinib, non-small cell lung cancer, first-line therapy, immune checkpoint inhibitors, antiangiogenic tyrosine kinase inhibitors, anti-PD-1 therapy, combination immunotherapy, chemotherapy-free regimen, tumor immune microenvironment, tumor angiogenesis, objective response rate, progression-free survival, treatment-related adverse events, hypertension, immune-related pneumonitis, PD-L1 expression
MeSH terms: Antineoplastic Combined Chemotherapy Protocols, Humans, Indoles, Lung Neoplasms, Protein-Tyrosine Kinases, Proto-Oncogene Proteins, Quinolines, Tumor Microenvironment, Antibodies, Monoclonal, Humanized

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Phase 1b Study of Sintilimab Plus Anlotinib as First-line Therapy in Patients With Advanced NSCLC

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