Han Chun, Ye Sisi, Hu Chunhong, Shen Liangfang, Qin Qun, Bai Yuxian, Yang Shizhong, Bai Chunmei, Zang Aimin, Jiao Shunchang, Bai Li
Department of Medical Oncology, Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
Department of Oncology, The Second Xiangya Hospital, Central South University, Changsha, China.
Front Oncol. 2021 Jul 13;11:684867. doi: 10.3389/fonc.2021.684867. eCollection 2021.
This study aims to assess the efficacy and safety of penpulimab (a humanized anti-PD-1 IgG1 antibody) with anlotinib in the first-line treatment of Chinese patients with uHCC.
In this open-label multicenter phase Ib/II trial, patients with histologically or cytologically confirmed uHCC, without previous systemic treatment, aged 18-75 years old, classified as BCLC stage B (not amenable for locoregional therapy) or C, with Child-Pugh score ≤7 and ECOG performance status ≤1 were enrolled. Patients received penpulimab [200 mg intravenous (i.v.) Q3W] and oral anlotinib (8 mg/day, 2 weeks on/1 week off). The primary endpoint was objective response rate (ORR). Secondary endpoints included safety, disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DoR), and overall survival (OS). This trial is registered with ClinicalTrials.gov (NCT04172571).
At the data cutoff (December 30, 2020), 31 eligible patients had been enrolled and treated with a median follow-up of 14.7 months (range, 1.4-22.1). The ORR was 31.0% (95% CI, 15.3-50.8%), and the DCR was 82.8% (95% CI, 64.2-94.2%). The median PFS and TTP for 31 patients were 8.8 months (95% CI, 4.0-12.3) and 8.8 months (95% CI, 4.0-12.9) respectively. The median OS was not reached; the 12-month OS rate was 69.0% (95% CI, 48.9-82.5%). Only 19.4% (6/31) of patients had grade 3/4 treatment-related adverse events (TRAEs).
Penpulimab plus anlotinib showed promising anti-tumor activity and a favorable safety profile as first-line treatment of patients with uHCC.
本研究旨在评估派安普利单抗（一种人源化抗PD-1 IgG1抗体）联合安罗替尼一线治疗中国uHCC患者的疗效和安全性。
在这项开放标签的多中心Ib/II期试验中，纳入了年龄在18至75岁之间、组织学或细胞学确诊为uHCC、未接受过全身治疗、BCLC分期为B期（不适合局部区域治疗）或C期、Child-Pugh评分≤7且ECOG体能状态≤1的患者。患者接受派安普利单抗[200 mg静脉注射（i.v.），每3周一次]和口服安罗替尼（8 mg/天，2周用药/1周停药）。主要终点为客观缓解率（ORR）。次要终点包括安全性、疾病控制率（DCR）、无进展生存期（PFS）、疾病进展时间（TTP）、缓解持续时间（DoR）和总生存期（OS）。本试验已在ClinicalTrials.gov注册（NCT04172571）。
在数据截止日期（2020年12月30日），31例符合条件的患者入组并接受治疗，中位随访时间为14.7个月（范围1.4 - 22.1个月）。ORR为31.0%（95%CI，15.3 - 50.8%），DCR为82.8%（95%CI，64.2 - 94.2%）。31例患者的中位PFS和TTP分别为8.8个月（95%CI，4.0 - 12.3）和8.8个月（95%CI，4.0 - 12.9）。中位OS未达到；12个月OS率为69.0%（95%CI，48.9 - 82.5%）。仅19.4%（6/31）的患者发生3/4级治疗相关不良事件（TRAEs）。
派安普利单抗联合安罗替尼作为uHCC患者的一线治疗显示出有前景的抗肿瘤活性和良好的安全性。
