Cited by 322Cancer Immunotherapy and BiomarkersLung Cancer Treatments and MutationsLung Cancer Diagnosis and Treatment

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Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12)

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Zhou, Caicun, Wu, Lin, Fan, Yun, Wang, Zhehai, Liu, Lianke, Chen, Gongyan, Zhang, Li, Huang, Dingzhi, Cang, Shundong, Yang, Zhixiong, Zhou, Jianying, Zhou, Chengzhi, Li, Baolan, Li, Juan, Fan, Min, Cui, Jiuwei, Li, Yuping, Zhao, Hui, Fang, Jian, Xue, Jianxin, Hu, Chengping, Sun, Ping, Du, Yingying, Zhou, Hui, Wang, Shuyan, Zhang, Wen·2021·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2021.04.011

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Abstract

Introduction The standard chemotherapy for squamous NSCLC (sqNSCLC) includes platinum plus gemcitabine. Sintilimab, an anti-programmed cell death protein 1 antibody, plus platinum and gemcitabine (GP) has revealed encouraging efficacy as first-line therapy for sqNSCLC in a phase 1b study. We conducted a randomized, double-blind, phase 3 study to further compare the efficacy and safety of sintilimab with placebo, both in combination with GP.Methods ORIENT-12, a randomized, double-blind, phase 3 study, was conducted at 42 centers in the People's Republic of China (ClinicalTrials.gov, number NCT03629925). Patients with locally advanced or metastatic sqNSCLC and without EGFR-sensitive mutations or ALK rearrangements were enrolled in the study. The stratification factors included clinical stage, choice of platinum, and programmed death-ligand 1 tumor proportion score. The patients, investigators, research staff, and sponsor team were masked to treatment assignment. Eligible patients were randomized 1:1, using an integrated web-response system, to receive sintilimab 200 mg or placebo plus GP every 3 weeks for four or six cycles, followed by sintilimab or placebo as maintenance therapy until disease progression or 2 years. The primary end point was progression-free survival (PFS), assessed by an independent radiographic review committee.Results Between September 25, 2018 and July 26, 2019, a total of 543 patients were screened, of whom 357 patients were randomized to the sintilimab-GP group (n = 179) and the placebo-GP group (n = 178). After a median follow-up period of 12.9 months, sintilimab-GP continued to reveal a meaningful improvement in PFS than placebo-GP (hazard ratio = 0.536 [95% confidence interval: 0.422-0.681], p < 0.00001). Treatment-emergent adverse events of grade 3 or worse occurred in 86.6% patients in the sintilimab-GP group and in 83.1% in the placebo-GP group. The incidence of treatment-emergent adverse event leading to death was 4.5% and 6.7% in the two treatment groups, respectively.Conclusions Regarding PFS, sintilimab plus GP reveals clinical benefit than GP alone as first-line therapy in patients with locally advanced or metastatic sqNSCLC. The toxicity was acceptable, and no new unexpected safety signals were observed.

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Authors: Zhou, C., Wu, L., Fan, Y., Wang, Z., Liu, L., Chen, G., Zhang, L., Huang, D., Cang, S., Yang, Z., Zhou, J., Zhou, C., Li, B., Li, J., Fan, M., Cui, J., Li, Y., Zhao, H., Fang, J., Xue, J., Hu, C., Sun, P., Du, Y., Zhou, H., Wang, S., & Zhang, W.
Affiliations: First Affiliated Hospital of Guangzhou Medical University (CN)
Hunan Cancer Hospital (CN)
University of Chinese Academy of Sciences (CN)
Shandong Tumor Hospital (CN)
Jiangsu Province Hospital (CN)
Harbin Medical University (CN)
Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
Tianjin Medical University Cancer Institute and Hospital (CN)
Henan Provincial People's Hospital (CN)
Guangdong Medical College (CN)
First Affiliated Hospital Zhejiang University (CN)
Capital Medical University (CN)
Sichuan Cancer Hospital (CN)
Fudan University Shanghai Cancer Center (CN)
First Hospital of Jilin University (CN)
First Affiliated Hospital of Wenzhou Medical University (CN)
Second Affiliated Hospital of Anhui Medical University (CN)
Peking University Cancer Hospital (CN)
Sichuan University (CN)
Xiangya Hospital Central South University (CN)
Yuhuangding Hospital (CN)
First Affiliated Hospital of Anhui Medical University (CN)
Innovent Biologics (China) (CN)
Corresponding author: Zhou, Caicun
ORCID: Zhou, Caicun
Wu, Lin
Fan, Yun
Wang, Zhehai
Zhang, Li
Huang, Dingzhi
Cang, Shundong
Yang, Zhixiong
Zhou, Jianying
Zhou, Chengzhi
Li, Baolan
Li, Juan
Fan, Min
Cui, Jiuwei
Li, Yuping
Zhao, Hui
Fang, Jian
Xue, Jianxin
Hu, Chengping
Sun, Ping
Du, Yingying
Zhou, Hui
Wang, Shuyan
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2021-09
Volume: 16
Issue: 9
Pages: 1501-1511
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2021.04.011
OpenAlex: W3165007730
Cited by: 322
References: 38
Citations by year: 2026: 42 · 2025: 62 · 2024: 71 · 2023: 70 · 2022: 71 · 2021: 6
FWCI: 19.84
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, 366 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: Eli Lilly and Company
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, lung squamous cell carcinoma, first-line therapy, immune checkpoint inhibitors, PD-1 inhibitors, progression-free survival, maintenance therapy, treatment-emergent adverse events, EGFR wild-type
MeSH terms: Gemcitabine, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Deoxycytidine, Double-Blind Method, Humans, Lung Neoplasms, Platinum, Antibodies, Monoclonal, Humanized

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Sintilimab Plus Platinum and Gemcitabine as First-Line Treatment for Advanced or Metastatic Squamous NSCLC: Results From a Randomized, Double-Blind, Phase 3 Trial (ORIENT-12)

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