Feng Yingfang, Liu Xia, Yu Jingwei, Song Zheng, Li Lanfang, Qiu Lihua, Zhou Shiyong, Qian Zhengzi, Wang Xianhuo, Zhang Huilai
Department of Lymphoma/National Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, The Sino-US Center for Lymphoma and Leukemia Research, Tianjin, China.
Expert Opin Biol Ther. 2025 Jan;25(1):9-14. doi: 10.1080/14712598.2024.2444400. Epub 2024 Dec 22.
Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive subtype arising from natural killer or cytotoxic T-cells, predominantly affecting the nasal cavity and paranasal sinuses, lacking a standardized therapeutic approach. Sugemalimab, a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb), has been investigated in a Single-Arm, Multicenter, Phase II Study (GEMSTONE-201). The results demonstrated significant efficacy, favorable tolerability, and manageable adverse reactions of sugemalimab in R/R ENKTL. This study summarizes and compares the efficacy and safety profile of sugemalimab with several other PD-1/PD-L1 inhibitors in R/R ENKTL patients.
We included a Phase II study (GEMSTONE-201) of sugemalimab in R/R ENKTL.
The clinical trials have demonstrated superior efficacy of sugemalimab, evidenced by a complete response rate (CRR) of 35.9% and an overall response rate (ORR) of 44.9%. In comparison with other immune checkpoint inhibitors (ICIs), sugemalimab shows a notably higher CRR. Additionally, sugemalimab exhibits a manageable safety profile. Further evaluation of sugemalimab is required based on its efficacy and safety in real-world patient populations. Should sugemalimab be included in medical insurance in the future, it could potentially benefit a larger number of patients with R/R ENKTL.
复发或难治性结外自然杀伤/T细胞淋巴瘤（R/R ENKTL）是一种罕见且侵袭性的亚型，起源于自然杀伤细胞或细胞毒性T细胞，主要累及鼻腔和鼻窦，缺乏标准化的治疗方法。舒格利单抗是一种全人源、全长抗PD-L1免疫球蛋白G4（IgG4）单克隆抗体（mAb），已在一项单臂、多中心、II期研究（GEMSTONE-201）中进行了研究。结果表明舒格利单抗在R/R ENKTL中具有显著疗效、良好的耐受性和可管理的不良反应。本研究总结并比较了舒格利单抗与其他几种PD-1/PD-L1抑制剂在R/R ENKTL患者中的疗效和安全性。
我们纳入了舒格利单抗在R/R ENKTL中的一项II期研究（GEMSTONE-201）。
临床试验已证明舒格利单抗具有卓越疗效，完全缓解率（CRR）为35.9%，总缓解率（ORR）为44.9%。与其他免疫检查点抑制剂（ICI）相比，舒格利单抗的CRR明显更高。此外，舒格利单抗的安全性易于管理。基于其在真实世界患者群体中的疗效和安全性，需要对舒格利单抗进行进一步评估。如果舒格利单抗未来被纳入医保，可能会使更多R/R ENKTL患者受益。
