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)

Zhou, Caicun; Wu, Lin; Fan, Yun; Wang, Zhehai; Liu, Lianke; Chen, Gongyan; Zhang, Li; Huang, Dingzhi; Cang, Shundong; Yang, Zhijian; 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

doi:10.1016/j.jtho.2021.04.011

Cited by 199 publications

(198 citation statements)

References 33 publications

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“…Randomized trials have revealed that anti-PD-1 mAbs (pembrolizumab and nivolumab) and anti-PD-L1 mAb (atezolizumab) provide additional benefits in both overall survival (OS) and progression-free survival (PFS) for patients with previously treated advanced NSCLC, compared with chemotherapy [ 7 , 8 , 9 , 10 , 11 ]. ICIs are also recommended as a first-line treatment for advanced or metastatic NSCLC, either as monotherapy or in combination with chemotherapy or other targeted agents, based on histology, genetic alterations, and level of PD-L1 expression [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ].…”

Section: Introductionmentioning

confidence: 99%

“…Currently, there are a variety of anti-cancer drugs available in the first-line treatment of advanced NSCLC, such as cytotoxic agents, targeted agents, and ICIs [ 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 ]. ICIs have transformed the paradigm of treatment for advanced NSCLC without EGFR , ALK , or ROS1 aberrations [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. However, randomized trials investigating the efficacy of ICIs as monotherapy or in combination with chemotherapy or other targeted agents are lacking for advanced NSCLC with high PD-L1 expression.…”

Section: Introductionmentioning

confidence: 99%

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A Bayesian Network Meta-Analysis of First-Line Treatments for Non-Small Cell Lung Cancer with High Programmed Death Ligand-1 Expression

Kim

Jeong

Lee

et al. 2022

JCM

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We performed a Bayesian network meta-analysis (NMA) to suggest frontline treatments for advanced non-small cell lung cancer (NSCLC) showing high programmed death ligand-1 (PD-L1) expression. A total of 5237 patients from 22 studies were included. In terms of progression-free survival, immune checkpoint inhibitors (ICIs) plus bevacizumab plus chemotherapy had the highest surface under the cumulative ranking curve (SUCRA) value (98.1%), followed by ICI plus chemotherapy (82.9%). In terms of overall survival (OS), dual immunotherapy plus chemotherapy had the highest SUCRA value (79.1%), followed by ICI plus bevacizumab plus chemotherapy (73.4%). However, there was no significant difference in survival outcomes among treatment regimens combined with immunotherapy. Moreover, ICI plus chemotherapy failed to reveal a significant OS superiority to ICI monotherapy (hazard ratio = 0.978, 95% credible internal: 0.771–1.259). In conclusion, this NMA indicates that ICI plus chemotherapy with/without bevacizumab might to be the best options in terms of OS for advanced NSCLC with high PD-L1 expression. However, considering that there was no significant difference in survival outcomes among treatment regimens incorporating immunotherapy and that ICI plus chemotherapy failed to show significant survival benefits over ICI monotherapy, ICI monotherapy may be reasonable as first-line treatment for advanced NSCLC with high PD-L1 expression.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Bayesian Network Meta-Analysis of First-Line Treatments for Non-Small Cell Lung Cancer with High Programmed Death Ligand-1 Expression

Kim

Jeong

Lee

et al. 2022

JCM

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“…An updated analysis after a 12.9-month median follow-up revealed a median PFS of 5.5 months in the combination treatment group vs. 4.9 months in the chemotherapy alone group (HR, 0.536; 95% CI, 0.422–0.681). Toxicities were similar in the two treatment groups ( 54 ).…”

Section: Ici As First-line Therapy For Advanced Nsclcmentioning

confidence: 87%

Immunotherapy in the First-Line Treatment of NSCLC: Current Status and Future Directions in China

2021

Self Cite

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Lung cancer causes significant morbidity and mortality in China and worldwide. In China, lung cancer accounts for nearly one-fourth of all cancer deaths. Non-small cell lung cancer (NSCLC) is the predominant type of lung cancer, accounting for approximately 80%–85% of all lung cancer cases. Immunotherapy with immune checkpoint inhibitors (ICIs) is revolutionizing the treatment of NSCLC. Immune checkpoint molecules, including PD-1/PD-L1 and CTLA-4, can suppress immune responses by delivering negative signals to T cells. By interfering with these immunosuppressive axes, ICIs unleash antitumor immune responses, ultimately eliminating cancer cells. ICIs have demonstrated promising antitumor efficacy in NSCLC, and mounting evidence supports the use of ICIs in treatment-naïve patients with advanced NSCLC. A comprehensive overview of current and emerging ICIs for the first-line treatment of NSCLC in China will facilitate a better understanding of NSCLC immunotherapy using ICIs and optimize the clinical use of ICIs in previously untreated Chinese patients with NSCLC. Herein, we review the efficacy and safety of currently approved and investigational ICIs as the first-line treatment of NSCLC in China. We also discuss the challenges limiting more widespread use of ICIs and future directions in the first-line treatment of NSCLC using ICIs.

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“…This approval was based on a phase III trial, ORIENT‐12, in which the 6‐month PFS was 41.4% and ORR was 64.7%. 304 …”

Section: Immunotherapy For Nsclcmentioning

confidence: 99%

Therapeutic advances in non‐small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy

Yuan

Zhang

2021

MedComm

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Lung cancer still contributes to nearly one‐quarter cancer‐related deaths in the past decades, despite the rapid development of targeted therapy and immunotherapy in non‐small cell lung cancer (NSCLC). The development and availability of comprehensive genomic profiling make the classification of NSCLC more precise and personalized. Most treatment decisions of advanced‐stage NSCLC have been made based on the genetic features and PD‐L1 expression of patients. For the past 2 years, more than 10 therapeutic strategies have been approved as first‐line treatment for certain subgroups of NSCLC. However, some major challenges remain, including drug resistance and low rate of overall survival. Therefore, we discuss and review the therapeutic strategies of NSCLC, and focus on the development of targeted therapy and immunotherapy in advanced‐stage NSCLC. Based on the latest guidelines, we provide an updated summary on the standard treatment for NSCLC. At last, we discussed several potential therapies for NSCLC. The development of new drugs and combination therapies both provide promising therapeutic effects on NSCLC.

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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)

Cited by 199 publications

References 33 publications

A Bayesian Network Meta-Analysis of First-Line Treatments for Non-Small Cell Lung Cancer with High Programmed Death Ligand-1 Expression

A Bayesian Network Meta-Analysis of First-Line Treatments for Non-Small Cell Lung Cancer with High Programmed Death Ligand-1 Expression

Immunotherapy in the First-Line Treatment of NSCLC: Current Status and Future Directions in China

Therapeutic advances in non‐small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy

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