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Open Access Article

International Medical Research Frontier. 2022; 6: (4) ; 12-19 ; DOI: 10.12208/j.imrf.20220127.

Establishment of a preliminary evaluation plan for the expanded application of a new domesticallyproduced PD-1 mAb——Taking Piamprimab as an example
新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例

作者: 王鹏翀, 朱亚宁, 史先鹏, 雍素云, 郝瑞芳, 张鹏 *

陕西省人民医院药学部 陕西西安

*通讯作者: 张鹏,单位:陕西省人民医院药学部 陕西西安;

发布时间: 2022-09-14 总浏览量: 349

摘要

目的 分析派安普利单抗的拓展性应用情况,建立新型国产程序性死亡受体-1(PD-1)单抗的拓展性应用的初步评价方案,为临床应用提供依据和参考。方法 收集药品信息和拓展性应用循证证据,确定拓展性应用范围;检索相关指南,对于已在国外获批适应症或已得到指南推荐的拓展性应用予以推荐;筛选已获批适应症或得到指南推荐的其他同类药品,通过可替代性评价给出拓展性应用推荐意见。结果 经初步筛选,确定8种拓展性应用;通过检索指南,对派安普利单抗在肝癌、鳞状非小细胞肺癌和鼻咽癌方面的拓展性应用予以推荐,对胃癌方面的应用不予推荐;通过可替代性评价对派安普利单抗头颈鳞癌、小细胞肺癌和胆管癌方面的拓展性应用进行推荐,对非鳞非小细胞肺癌方面的应用不予推荐。结论 建立了一种通过指南检索和同类竞品对比从而快速评价新型国产PD-1单抗拓展性应用的初步方案。

关键词: 派安普利单抗;国产PD-1单抗;拓展性应用;可替代性;快速评价

Abstract

Objective To analyze the expanded application of piamprilumab, establish a preliminary evalua- tion plan for the expanded application of a new domestic programmed death receptor-1 (PD-1) monoclonal anti- body, and provide basis and reference for clinical application.
Methods Collect drug information and evidence- based evidence of extended application to determine the scope of extended application; search relevant guidelines, and recommend extended applications that have been approved in foreign countries or have been recommended by guidelines; screened the approved indications or obtained For other similar drugs recommended by the guideline, recommendations for extended application are given through substitutable evaluation.
Results After preliminary screening, 8 expanded applications were identified; through the search guide, the expanded application of piam- prilumab in liver cancer, squamous non-small cell lung cancer and nasopharyngeal carcinoma was recommended, but not in gastric cancer. It is recommended; the expanded application of pianpilimumab in head and neck squamous cell carcinoma, small cell lung cancer, and cholangiocarcinoma is recommended through the evaluation of surrogacy, and the application in non-squamous non-small cell lung cancer is not recommended.
Conclusion   A preliminary scheme for rapid evaluation of the expandable application of the new domestic PD-1 mAb was established through the guideline search and comparison of similar competing products.

Key words: Pienpilimumab; Domestic PD-1 mAb; Expanded Application; Substitutability; Rapid Evaluation

参考文献 References

[1] Okazaki T, Chikuma S, Iwai Y, et al. A rheostat for immune responses: the unique properties of PD-1 and their advantages for clinical application [J]. Nat Immunol, 2013, 14(12): 1212-8.

[2] 政策法规司.中华人民共和国医师法:中华人民共和国主席令(第94号) [EB/OL]. (2021-08-20) [2022-04-18]. http://www.gov.cn/xinwen/2021-08/20/content_5632496.htm.

[3] 湖北省医院协会要是专业委员会《湖北省医疗机构药品拓展性临床应用管理专家共识》编写组.湖北省医疗机构药品拓展性临床应用管理专家共识 [J]. 医药导报.

[4] Xu N, Han B, Jiao S, et al. 31P Integrated safety analysis of anti-programmed cell death-1 (PD-1) antibody penpulimab in advanced solid tumour or lymphoma[J]. Annals of Oncology, 2020, 31: S1428-S9.

[5] Li B, Chan H L, Chen P. Immune Checkpoint Inhibitors: Basics and Challenges [J]. Curr Med Chem, 2019, 26(17): 3009-25.

[6] Sun C, Mezzadra R, Schumacher TN. Regulation andFunction of the PD-L1 Checkpoint [J]. Immunity, 2018, 48(3): 434-52.

[7] Zheng Y, Mislang ARA, Coward J, et al. Penpulimab,an anti-PD1 IgG1 antibody in the treatment of advanced or metastatic upper gastrointestinal cancers [J]. Cancer Immunol Immunother, 2022.

[8] Han C, Ye S, Hu C, et al. Clinical Activity and Safety of Penpulimab (Anti-PD-1) With Anlotinib as First-Line Therapy for Unresectable Hepatocellular Carcinoma: An Open-Label, Multicenter, Phase Ib/II Trial (AK105-203) [J]. Front Oncol, 2021, 11: 684867.

[9] Jiao S.C., Bai L, Dong J. Clinical activity and safetyof penpulimab (Anti-PD-1) with anlotinib as first-line therapy for advanced hepatocellular carcinoma (HCC) [J]. Journal of Clinical Oncology, 2020, 38: 15.

[10] Paz-Ares, Luis, Ciuleanu, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (checkmate 9la): an international, randomised, open-label, phase 3 trial [J]. The Lancet Oncology, 22(2): 198-211.

[11] Han B, Chen J, Wang Z. Penpulimab in combination with anlotinib as first-line treatment in advanced nonsquamousnonsmall-cell lung cancer [J]. Journal of Clinical Oncology, 2021, 39: 15 SUPPL

[12] Dhillon S. Penpulimab: First Approval [J]. Drugs, 2021, 81(18): 2159-66.

[13] Zhang C, Yang S, Chen J. Penpulimab plus anlotinib as second-line treatment for the small cell lung cancer after failure of platinum-based systemic chemotherapy [J]. Journal of Clinical Oncology, 2021, 39: 15 SUPPL

[14] Shi Y.-K, Gao L, Tian Y. Efficacy and safety of penpulimab plus anlotinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): A phase II study [J]. Annals of Oncology, 2021, 32(S806): Supplement 5.

[15] Chen X, Hu C, Wang W. A phase II study of the anti-programmed cell death-1 (PD-1) antibody penpulimab in patients with metastatic nasopharyngeal carcinoma (NPC) who had progressed after two or more linesof chemotherapy: Updated results [J]. Annals of Oncology, 2021, 32(S806): Supplement 5.

[16] Mislang A R A, Coward J, Cooper A, et al. 157P Efficacy and safety of penpulimab (AK105), a new generation anti-programmed cell death-1 (PD-1) antibody,in upper gastrointestinal cancers [J]. Annals of Oncology, 2020, 31: S1300-S1.

[17] Zhou C, Chen G, Huang Y, et al. Camrelizumab pluscarboplatin and pemetrexed versus chemotherapy alone in chemotherapy-naive patients with advanced non-squamous non-small-cell lung cancer (CameL): a randomised, open-label, multicentre, phase 3 trial [J]. Lancet Respir Med, 2021, 9(3): 305-314.

[18] Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck [J]. N Engl J Med, 2016, 375 (19): 1856-1867.

[19] Harrington KJ, Ferris RL, Blumenschein G Jr, et al. Nivolumab versus standard, single-agent therapy of investigator's choice in recurrent or metastatic squamouscell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial [J]. Lancet Oncol, 2017, 18 (8): 1104-1115

[20] Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 withanalyses by tumor PD-L1 expression [J]. Oral Oncol, 2018, 81: 45-51.

[21] Fan Y, Zhao J, Wang Q, et al. Camrelizumab Plus Apatinib in Extensive-Stage SCLC (PASSION): a multicenter, two-stage, phase 2 Trial [J]. J Thorac Oncol, 2021, 16 (2): 299-309.

[22] Kim RD, Chung V, Alese OB, et al. A Phase 2 Multi-institutional Study of Nivolumab for Patients With Advanced Refractory Biliary Tract Cancer. JAMA Oncol, 2020, 6(6): 888-894.

引用本文

王鹏翀, 朱亚宁, 史先鹏, 雍素云, 郝瑞芳, 张鹏, 新型国产PD-1单抗拓展性应用初步评价方案建立——以派安普利单抗为例[J]. 国际医药研究前沿, 2022; 6: (4) : 12-19.