PDF(Pubmed)
Abstract：
Penpulimab is an anti-programmed cell death-1 (PD-1) IgG1 antibody with no Fc gamma receptor (FcγR) binding activity, and thus theoretically reduced immune-related adverse events (irAEs) while maintaining efficacy. This single-arm, phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma (NPC) who had failed two or more lines of previous systemic chemotherapy. Patients received 200-mg penpulimab intravenously every 2 weeks (4 weeks per cycle) until disease progression or intolerable toxicities. The primary endpoint was objective response rate (ORR) per RECIST (version 1.1), as assessed by an independent radiological review committee. The secondary endpoints included progression-free survival (PFS) and overall survival (OS). One hundred thirty patients were enrolled and 125 were efficacy evaluable. At the data cutoff date (September 28, 2022), 1 patient achieved complete response and 34 patients attained partial response. The ORR was 28.0% (95% CI 20.3-36.7%). The response was durable, with 66.8% still in response at 9 months. Thirty-three patients (26.4%) were still on treatment. The median PFS and OS were 3.6 months (95% CI = 1.9-7.3 months) and 22.8 months (95% CI = 17.1 months to not reached), respectively. Ten (7.6%) patients experienced grade 3 or higher irAEs. Penpulimab has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients, supporting further clinical development as third-line treatment of metastatic NPC.
摘要：
Penpulimab是一种抗程序性细胞死亡-1（PD-1）IgG1抗体，没有Fcγ受体（FcγR）结合活性，因此理论上减少了免疫相关的不良事件（irAEs），同时保持疗效。这个单臂，在中国20个三级医疗中心进行的II期试验纳入了先前两次或两次以上全身化疗失败的转移性鼻咽癌(NPC)成年患者.患者每2周（每个周期4周）静脉注射200mgpenpulimab，直到疾病进展或无法耐受的毒性。主要终点是根据RECIST（1.1版）的客观缓解率（ORR），由独立的放射审查委员会评估。次要终点包括无进展生存期（PFS）和总生存期（OS）。入选130例患者，其中125例疗效可评估。在数据截止日期（2022年9月28日），1例患者获得完全反应，34例患者获得部分反应。ORR为28.0%（95%CI20.3-36.7%）。反应是持久的，在9个月时仍有66.8%的反应。33例患者（26.4%）仍在接受治疗。中位PFS和OS分别为3.6个月（95％CI=1.9-7.3个月）和22.8个月（95％CI=17.1个月未达到），分别。10名(7.6%)患者经历了3级或更高的irAE。Penpulimab在严重预处理的转移性NPC患者中具有有希望的抗肿瘤活性和可接受的毒性，支持作为转移性NPC的三线治疗的进一步临床开发。
