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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)
Open accessAbstract
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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“In addition, the NMPA approved sintilimab plus gemcitabine and platinum as the first-line treatment for advanced squamous NSCLC, based on the results of ORIENT-12 [60].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [60]
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Metadata
- 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
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2021-09
- Volume
- 16
- Issue
- 9
- Pages
- 1501-1511
- ISSN
- 1556-0864 (ISSN-L)
- 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
- 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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