Objective  To evaluate the efficacy, safety and economy of sugemalimab in the first-line treatment of non-small cell lung cancer (NSCLC) by rapid health technology assessment.

Methods  PubMed, Cochrane Library, Embase, CNKI, WanFang Data, VIP and official websites of health technology assessment (HTA) institutions were systematically searched to collect HTA reports, systematic reviews/Meta-analysis and pharmacoeconomic studies of sugemalimab in first-line treatment of NSCLC from inception to October 31, 2024. Two reviewers independently screened the literature, extracted information and performed quality assessment of the included studies, and then performed descriptive analysis on the results.

Results  A total of 15 articles were selected, including 4 systematic reviews/Meta-analysis and 11 pharmacoeconomic studies. In terms of effectiveness, compared with chemotherapy alone, sugemalimab combined with chemotherapy significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in patients with NSCLC. In terms of safety, compared with chemotherapy alone, sugemalimab combined chemotherapy had higher incidence of overall adverse events, but it had a better safety profile compared to other immune combination therapies. In terms of economy, most studies suggested that compared with chemotherapy alone, sugemalimab combined with chemotherapy was not cost-effective, which may be related to the high price of sugemalimab. However, a few studies indicated that sugemalimab combined with chemotherapy could be cost-effective in specific scenarios.

Conclusion  Sugemalimab has good efficacy in the first-line treatment of NSCLC, but its safety and economy need to be further studied.

1.Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2021, 71(3): 209-249. DOI: 10.3322/caac.21660.

2.Auperin A, Rolland E, Curran WJ, et al. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer[J]. J Clin Oncol, 2010, 28(13): 2181-2190. DOI: 10.1200/jco.2009.26.2543.

3.Hsiao SH, Chung CL, Chou YT, et al. Identification of subgroup patients with stage ⅢB/Ⅳ non-small cell lung cancer at higher risk for brain metastases[J]. Lung Cancer, 2013, 82(2): 319-323. DOI: 10.1016/j.lungcan.2013.08.004.

4.Xia L, Liu Y, Wang Y. PD-1/PD-L1 blockade therapy in advanced non-small-cell lung cancer: current status and future directions[J]. Oncologist, 2019, 24(Suppl 1): S31-S41. DOI: 10.1634/theoncologist.2019-IO-S1-s05.

5.Bi N, Wang Y, Wang L. Sequential chemoradiotherapy followed by sugemalimab for locally advanced NSCLC[J]. Lancet Oncol, 2022, 23(4): e158. DOI: 10.1016/s1470-2045(22)00133-4.

6.Zhou Q, Chen M, Jiang O, et al. Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage Ⅲ non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial[J]. Lancet Oncol, 2022, 23(2): 209-219. DOI: 10.1016/s1470-2045(21)00630-6.

7.Rosell R, González-Cao M. Ablating lung cancer, knowing the tumor better[J]. Lancet Reg Health Eur, 2022, 22: 100494. DOI: 10.1016/j.lanepe.2022.100494.

8.Dhillon S, Duggan S. Sugemalimab: first approval[J]. Drugs, 2022, 82(5): 593-599. DOI: 10.1007/s40265-022-01693-4.

9.朱正飞, 谭佩欣. GEMSTONE-301: 同步/序贯放化疗后舒格利单抗巩固治疗可提高不可手术的Ⅲ期非小细胞肺癌患者的生存[J]. 循证医学, 2022, 22(1): 4-7. [Zhu ZF, Tan PX. GEMSTONE-301: sugemalimab as a consolidation treatment chemoradiotherapy improves the survival of patients with unresectable stage Ⅲ non-small cell lung cancer[J]. The Journal of Evidence-Based Medicine, 2022, 22(1): 4-7.] DOI: 10.12019/j.issn.1671-5144.2022.01.002.

10.Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage Ⅲ non-small-cell lung cancer[J]. N Engl J Med, 2017, 377(20): 1919-1929. DOI: 10.1056/NEJMoa1709937.

11.刘梦娜, 吴斌, 艾丹丹, 等. 药物快速卫生技术评估方法学研究——以抗肿瘤用药为例[J]. 中国药房, 2022, 33(11): 1386-1391. [Liu MN, Wu B, Ai DD, et al. Methodological study of rapid health technology assessment of drugs: taking antitumor drugs as an example[J]. China Pharmacy, 2022, 33(11): 1386-1391.] DOI: 10.6039/j.issn.1001-0408.2022.11.18.

12.李苗苗, 吴雪, 徐思敏, 等. 快速卫生技术评估的概况性综述 [J]. 中国中药杂志, 2022, 47(12): 3125-3135. [Li MM, Wu X, Xu SM, et al. Scoping review of rapid health technology assessment[J]. China Journal of Chinese Materia Medica, 2022, 47(12): 3125-3135.] DOI: 10.19540/j.cnki.cjcmm.20220315.503.

13.郭武栋, 刘梦娜, 潘伟, 等. 快速卫生技术评估国际经验介绍 [J]. 中国医疗保险, 2022(9): 124-127. [Guo WD, Liu MN, Pan W, et al. Introduction to international experience in rapid health technology assessment[J]. China Healthcare Security, 2022(9): 124-127.] DOI: 10.19546/j.issn.1674-3830.2022.9.026.

14.Hailey D. Toward transparency in health technology assessment: a checklist for HTA reports[J]. Int J Technol Assess Health Care, 2003, 19(1): 1-7. DOI: 10.1017/s0266462303000011.

15.Shea BJ, Reeves BC, Wells G, et al. AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both[J]. BMJ, 2017, 358: 4008. DOI: 10.1136/bmj.j4008.

16.邢质聪, 孙福东, 薛青霞, 等. 4种静脉铁剂治疗缺铁性贫血的快速卫生技术评估[J]. 药物流行病学杂志, 2024, 33(9): 1030-1043. [Xing ZC, Sun FD, Xue QX, et al. Four intravenous iron formulations in the treatment of iron deficiencyanemia: a rapid health technology assessment[J]. Chinese Journal of Pharmacoepidemiology, 2024, 33(9): 1030-1043.] DOI: 10.12173/j.issn.1005-0698.202406030.

17.Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations[J]. Value Health, 2022, 25(1): 3-9. DOI: 10.1016/j.jval.2021.11.1351.

18.Li Y, Liang X, Li H, et al. Efficacy and safety of immune checkpoint inhibitors for advanced non-small cell lung cancer with or without PD-L1 selection: a systematic review and network Meta-analysis[J]. Chin Med J (Engl), 2023, 136(18): 2156-2165. DOI: 10.1097/cm9.0000000000002750.

19.Wenfan F, Manman X, Xingyuan S, et al. Comparison of the profiles of first-line PD-1/PD-L1 inhibitors for advanced NSCLC lacking driver gene mutations: a systematic review and Bayesian network Meta-analysis[J]. Ther Adv Chronic Dis, 2023, 14: 20406223231189224. DOI: 10.1177/20406223231189224.

20.Zhao M, Shao T, Ren Y, et al. 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[J]. Front Pharmacol, 2022, 13: 910656. DOI: 10.3389/fphar.2022.910656.

21.Yang Y, Chen W, Dong L, et al. Comparison of efficacy and safety of PD-1/PD-L1 combination therapy in first-line treatment of advanced NSCLC: an updated systematic review and network Meta-analysis[J]. Clin Transl Oncol, 2024, 26(10): 2488-2502. DOI: 10.1007/s12094-024-03442-3.

22.申子涵, 梁锦莹, 张炜晨, 等. 舒格利单抗用于放化疗后未发生疾病进展不可切除的Ⅲ期非小细胞肺癌的药物经济学评价[J]. 中国药物经济学, 2023, 18(5): 12-17. [Shen ZH, Liang JY, Zhang WC, et al. Pharmacoeconomic evaluation of sugemalimab in the treatment of unresectable locally advanced (stage Ⅲ) non-small cell lung cancer[J]. Chinese Journal of Pharmacoeconomics, 2023, 18(5): 12-17.] DOI: 10.12010/j.issn.1673-5846.2023.05.002.

23.苏杭, 王琳, 韩晟, 等. 舒格利单抗巩固治疗Ⅲ期非小细胞肺癌的药物经济学评价[J]. 中国药房, 2023, 34(13):1606-1610. [Su H, Wang L, Han S, et al. Pharmacoeconomic evaluation of sugemalimab consolidation therapy for stage Ⅲ non-small cell lung cancer[J]. China Pharmacy, 2023, 34(13): 1606-1610.] DOI: 10.6039/j.issn.1001-0408.2023.13.12.

24.Chen X, Zhao M, Tian L, et al. Economic evaluation of five first-line PD-(L)1 inhibitors for treating non-squamous non-small cell lung cancer in China: a cost-effectiveness analysis based on network Meta-analysis[J]. Front Pharmacol, 2023, 14: 1119906. DOI: 10.3389/fphar.2023.1119906.

25.Li W, Wan L. A trial-based cost-utility analysis of sugemalimab vs. placebo as consolidation therapy for unresectable stage Ⅲ NSCLC in China[J]. PLoS One, 2023, 18(6): e0286595. DOI: 10.1371/journal.pone.0286595.

26.Liang X, Chen X, Li H, et al. Sugemalimab plus chemotherapy vs. chemotherapy for metastatic non-small-cell lung cancer: a cost-effectiveness analysis[J]. Front Public Health, 2023, 11: 1054405. DOI: 10.3389/fpubh.2023.1054405.

27.Zhao M, Shao T, Chi Z, et al. Effectiveness and cost-effectiveness analysis of 11 treatment paths, seven first-line and three second-line treatments for Chinese patients with advanced wild-type squamous non-small cell lung cancer: a sequential model[J]. Front Public Health, 2023, 11: 1051484. DOI: 10.3389/fpubh.2023.1051484.

28.Cheng R, Zhou Z, Liu Q. The cost-effectiveness of sugemalimab plus chemotherapy as first-line treatment for metastatic squamous and non-squamous NSCLC in China[J]. Adv Ther, 2023, 40(10): 4298-4309. DOI: 10.1007/s12325-023-02594-y.

29.Li W, Wan L. Cost-effectiveness analysis of sugemalimab vs. placebo, in combination with chemotherapy, for treatment of first-line metastatic NSCLC in China[J]. Front Public Health, 2022, 1015702. DOI: 10.3389/fpubh.2022.1015702.

30.Wang H, Liao L, Xu Y, et al. Economic evaluation of first-line sugemalimab plus chemotherapy for metastatic non-small cell lung cancer in China[J]. Front Oncol, 2022, 12: 1081750. DOI: 10.3389/fonc.2022.1081750.

31.Zheng Z, Zhu H, Fang L, et al. Cost-effectiveness analysis of sugemalimab vs. chemotherapy as first-line treatment of metastatic nonsquamous non-small cell lung cancer[J]. Front Pharmacol, 2022, 13: 996914. DOI: 10.3389/fphar.2022.996914.

32.Chen P, Li Y, Jing X, et al. Cost-effectiveness analysis of sugemalimab in combination with chemotherapy as first-line treatment in Chinese patients with metastatic NSCLC[J]. Lung Cancer, 2022, 174: 157-164. DOI: 10.1016/j.lungcan.2022.11.008.

33.Rosell R, Cao P. Promising outlook with sugemalimab in non-small-cell lung cancer[J]. Lancet Oncol, 2022, 23(2): 186-188. DOI: 10.1016/s1470-2045(21)00698-7.