MA13.08 CHOICE-01: A Phase 3 Study of Toripalimab Versus Placebo in Combination With First-Line Chemotherapy for Advanced NSCLC

Wang, J.; Wang, Z.; Wu, Lin; Li, B.; Cheng, Yin; Li, X.; Wang, X.; Han, Liz Y.; Wu, Xiufeng; Fan, Yun; Ye, Yu; Lv, Dongqing; Shi, Jianping; Huang, Jian; Zhou, Song; Han, Baohui; Sun, Guohua; Guo, Qishuai; Y, Ji; Zhu, Xiaoyun; Hu, Sylvia; Zhang, W.; Wang, Q.; Jia, Yaqi; Song, Yuxian; Wu, Jieli; Shi, Man-Jie; Han, Ze‐Guang; Liu, Y.; Yu, Zhuang; Liu, A.; Zhou, Cathy; Zhong, Diansheng; Miao, Liyun; Zhang, Z.; Zhao, Hui; Yang, Jiliang; Wang, D.; Wang, Y.; Li, Qiang; Zhang, X.; Ji, Martín-Valadés; Yang, Zeyu; Cui, Jingwen; Gao, Beili; Wang, B.; Liu, H.; Nie, Lei; He, Min; Jin, Sanli; Gu, Weiwei; Shu, Yongqian; Zhou, Ting; Feng, J.; Yang, Xi; Huang, Chen; Zhu, Bo; Yao, Yu; Kang, Xun; Yao, Shirley; Keegan, Patricia

doi:10.1016/j.jtho.2021.08.181

Cited by 11 publications

(7 citation statements)

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“…The preliminary results in terms of DIC and DI, nivolumab combined with ipilimumab, with or without CT, subsequently have been considered the most effective novel dual immunological applicability to treat NSCLC [ 19 , 30 , 31 ]. Since the data of the non-squamous NSCLC subgroup were not provided in the MYSTIC, CHOICE-01, Empower-Lung 3, and POSEIDON studies, these four studies were not included in this NMA [ 32 , 33 , 34 , 35 ]. There was no significant difference in OS and PFS among the four ICI-based therapies (BIC, IC, DI, and DIC).…”

Section: Discussionmentioning

confidence: 99%

Combined Immunotherapy with Chemotherapy versus Bevacizumab with Chemotherapy in First-Line Treatment of Driver-Gene-Negative Non-Squamous Non-Small Cell Lung Cancer: An Updated Systematic Review and Network Meta-Analysis

Chai

Bai

et al. 2022

JCM

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Background: A network meta-analysis was conducted to summarize randomized control trials and updated results to evaluate the efficacy and safety profiles of existing first-line therapies for advanced non-squamous non-small cell lung cancer (NSCLC) patients without known driver gene mutations. Patients and Methods: Eligible studies were identified following a systematic search of the Cochrane Library, PubMed, Embase, Web of Science, Wanfang Data, and the China Knowledge Resource Integrated Database from January 2000 to December 2021. Results: Nineteen trials involving 8176 patients with driver-gene-negative advanced non-squamous NSCLC were included. For patients with driver-gene-negative advanced NSCLC, immunotherapy + chemotherapy (IC) significantly prolonged overall survival (OS) (hazard ratio (HR), 0.80; 95% confidence intervals (CI): 0.67–0.95) and progression-free survival (PFS) (HR, 0.68; 95% CI: 0.53–0.86) compared with bevacizumab + chemotherapy (BC), with a similar objective response rate and incidence of ≥3 treatment-related adverse events (TRAEs) (risk ratios (RR), 0.98; 95% CI: 0.79–1.21/RR, 0.89; 95% CI: 0.61–1.28; respectively) compared with BC. IC yielded a superior PFS rate (HR, 1.59; 95% CI: 1.05–2.38) compared to BC in the subgroup of patients < 65 years old. Conclusions: Currently, IC is a more efficient first-line therapy for driver-gene-negative advanced non-squamous NSCLC patients, with prolonged PFS and OS, as well as a comparatively lower risk of ≥3 TRAEs compared to BC.

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Section: Discussionmentioning

confidence: 99%

Combined Immunotherapy with Chemotherapy versus Bevacizumab with Chemotherapy in First-Line Treatment of Driver-Gene-Negative Non-Squamous Non-Small Cell Lung Cancer: An Updated Systematic Review and Network Meta-Analysis

Chai

Bai

et al. 2022

JCM

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“…Although ICIs have been approved for the treatment of patients with advanced NSCLC, regardless of histology, whether they deliver different clinical efficacy in SQ-NSCLC and non-SQ-NSCLC remains controversial ( 22 ). The survival benefits were larger in SQ-NSCLC compared with non-SQ-NSCLC in some trials (KEYNOTE-042 ( 30 ), CheckMate 026 ( 32 ), CheckMate 227 ( 16 ), CheckMate 078 ( 35 )), and were similar in OAK ( 10 ), POPLAR ( 7 ) and CHOICE-01 ( 52 ), but were smaller in KEYNOTE-010 ( 34 ) and KEYNOTE-024 ( 8 ). To investigate if there is a difference in the efficacy of ICIs between SQ-NSCLC and non-SQ-NSCLC, we conducted this systematic review and meta-analysis.…”

Section: Discussionmentioning

confidence: 98%

Effect of histology on the efficacy of immune checkpoint inhibitors in advanced non-small cell lung cancer: A systematic review and meta-analysis

Zhai

et al. 2022

Front. Oncol.

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BackgroundLittle is known about the effect of histology on the efficacy of immune checkpoint inhibitors (ICI) in non-small-cell lung cancer (NSCLC). We conducted a systematic review and meta-analysis to assess the potential differences in the efficacy of ICIs between squamous NSCLC (SQ-NSCLC) and non-squamous NSCLC (non-SQ-NSCLC).MethodsSystematic searches of PubMed, Embase, Scopus, and Cochrane Library databases were conducted. All randomized clinical trials of ICIs with available hazard ratios (HR) for progression-free survival (PFS) or overall survival (OS) according to histology were included. The primary endpoint was to assess the difference in the efficacy of ICIs between SQ-NSCLC and non-SQ-NSCLC, measured by the ratio of the HR in SQ-NSCLC to the HR in non-SQ-NSCLC (RHR).ResultsA total of 40 trials were included in the meta-analysis. ICI monotherapy could improve OS in both SQ-NSCLC (OS-HR 0.71, 95% CI 0.65-0.77) and non-SQ-NSCLC (OS-HR 0.80, 95% CI 0.73-0.87) while OS benefit was larger in SQ-NSCLC (OS-RHR 0.89, 95% CI 0.80-0.99). In terms of PFS, ICI monotherapy could reduce the risk of progression by 35% (PFS-HR 0.65, 95% CI 0.56-0.77) in SQ-NSCLC while the PFS benefit was smaller (10%) and not statistically significant in non-SQ-NSCLC (PFS-HR 0.90, 95% CI 0.76-1.07). Similarly, ICI-based combination treatments could reduce the risk of both progression and death in SQ-NSCLC (OS-HR 0.70, 95% CI 0.61-0.80; PFS-HR 0.56, 95% CI 0.48-0.65) and non-SQ-NSCLC (OS-HR 0.78, 95% CI 0.74-0.83; PFS-HR 0.63, 95% CI 0.57-0.69) while the survival benefits were larger in SQ-NSCLC (OS-RHR 0.83, 95% CI 0.70-0.99; PFS-RHR 0.82, 95% CI 0.70-0.96).ConclusionsICIs could deliver survival benefits in both SQ-NSCLC and non-SQ-NSCLC while the magnitude of survival benefits was histology-dependent. Future researches should consider the effect of histology on the efficacy of ICIs.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier [CRD42022299603].

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“…This analysis was necessary given that non-PH were detected in the most included trial of our study. ( Jotte et al, 2020 ; Paz-Ares et al, 2020 ; Wang et al, 2021 ; Wang et al, 2021 ; Zhou et al, 2022 ; Zhou et al, 2021 ). Furthermore, our subgroup analysis of PD-(L)1 expression, smoking, gender, ECOG performance status, age and disease stage can provide reference for clinical precision medicine.…”

Section: Discussionmentioning

confidence: 99%

Identifying optimal PD-1/PD-L1 inhibitors in first-line treatment of patients with advanced squamous non-small cell lung cancer in China: Updated systematic review and network meta-analysis

Zhao

Shao²,

Ren³

et al. 2022

Front. Pharmacol.

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Objective: After Gemstone-302 was published in Lancet in January 2022, seven PD-(L)1 inhibitors launched or about to be launched in China, but there are no head-to-head RCTs reporting the comparative efficacy for squamous non-small cell lung cancer (sq-NSCLC). Therefore, we aimed to indirectly compare the efficacy of these treatments to provide evidence for clinical decision and Chinese national reimbursement drug listing.Methods: We collected phase III clinical trials targeted on stage IIIB–IV patients for first-line immunotherapy of sq-NSCLC by systematically searching databases. Relative effects of competing treatments were assessed by Bayesian network meta-analysis and non-parametric restricted mean survival time (RMST) model. Hazard ratio (HR), severe adverse events (SAEs, grade 3–5), progression-free survival (PFS) and overall survival (OS) years were the outcomes. Subgroup analysis was done according to PD-(L)1 expression, smoking, gender, Eastern Cooperative Oncology Group performance status, age and disease stage. Sensitivity analysis using the range of parameters distribution as well as different comparison methods was performed to test the robustness of the results.Results: A total of 7 clinical trials with 2,640 patients were included. For OS, the efficiency (HR, 95%CI) ranks from high to low were sugemalimab (0.48, 0.32–0.73), camrelizumab (0.55, 0.40–0.76), sintilimab (0.56, 0.35–0.90), pembrolizumab (0.71, 0.58–0.87) and atezolizumab (0.88, 0.73–1.05). For PFS, the efficiency ranks from high to low were sugemalimab (0.33, 0.24–0.45), camrelizumab (0.37, 0.30–0.46), tislelizumab (0.53, 0.36–0.79), sintilimab (0.54, 0.42–0.69), toripalimab (0.56, 0.38–0.83), pembrolizumab (0.57, 0.47–0.70) and atezolizumab (0.71, 0.59–0.85). Proportional hazard models and non-proportional hazard models showed consistent efficiency ranks. When extrapolated to long-term survival benefit, under non-proportional hazard ratio, sugemalimab achieved the highest PFS benefit (lifeyears, LYs) in 2 years (1.323), with camrelizumab (1.320), sintilimab (1.243), tislelizumab (1.189), pembrolizumab (0.990) and atezolizumab (0.947) ranking in order; Camrelizumab achieved the highest OS benefit (LYs) in 10 years (2.723), with atezolizumab (2.445) and pembrolizumab (2.397) ranking in order. RMST model showed similar results. In terms of safety, PD-(L)1 inhibitors increased the incidence of SAEs when combined with chemotherapy, sugemalimab and camrelizumab was the safest drugs.Conclusion: Sugemalimab is superior both in HR and long-term survival benefit for Chinese patients with advanced sq-NSCLC.

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MA13.08 CHOICE-01: A Phase 3 Study of Toripalimab Versus Placebo in Combination With First-Line Chemotherapy for Advanced NSCLC

Cited by 11 publications

References 0 publications

Combined Immunotherapy with Chemotherapy versus Bevacizumab with Chemotherapy in First-Line Treatment of Driver-Gene-Negative Non-Squamous Non-Small Cell Lung Cancer: An Updated Systematic Review and Network Meta-Analysis

Combined Immunotherapy with Chemotherapy versus Bevacizumab with Chemotherapy in First-Line Treatment of Driver-Gene-Negative Non-Squamous Non-Small Cell Lung Cancer: An Updated Systematic Review and Network Meta-Analysis

Effect of histology on the efficacy of immune checkpoint inhibitors in advanced non-small cell lung cancer: A systematic review and meta-analysis

Identifying optimal PD-1/PD-L1 inhibitors in first-line treatment of patients with advanced squamous non-small cell lung cancer in China: Updated systematic review and network meta-analysis

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