The Ohio State University, James Comprehensive Cancer Center, Columbus, OH, United States. Electronic address: David.O'
Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Gynecol Oncol. 2021 Nov;163(2):274-280. doi: 10.1016/j.ygyno.2021.08.018. Epub 2021 Aug 25.
This phase II clinical trial evaluated the safety and antitumor activity of balstilimab, an anti-PD-1 antibody, in patients with previously-treated, recurrent/metastatic cervical cancer.
Eligible patients were 18 years or older with recurrent and/or metastatic cervical cancer and who had relapsed after a prior platinum-based treatment regimen for advanced disease. Balstilimab was administered intravenously at 3 mg/kg once every two weeks, for up to 24 months. The primary endpoint was objective response rate (ORR, RECIST v1.1) as assessed by an independent review committee.
At data cutoff, 161 women (median age, 53 years [range 25-81]) were enrolled and treated with balstilimab. Of these, 140 had measurable disease at baseline and one prior line of platinum-based therapy in the metastatic, persistent, or recurrent setting; these patients were included in the efficacy analyses. The ORR was 15% (95% CI, 10.0%-21.8%) and included 5 patients with a complete response and 16 with a partial response. The median duration of response was 15.4 months. In patients with PD-L1-positive tumors the ORR was 20%, however patients with PD-L1-negative tumors also responded to balstilimab (ORR, 7.9%). Responses were not restricted to tumors of squamous cell histology, and an ORR of 12.5% was seen in the subset of patients with cervical adenocarcinoma. The disease control rate was 49.3% (95% CI, 41.1%-57.5%). Immune-mediated enterocolitis (3.1%) and diarrhea (1.9%) were the most common grade 3 or higher treatment-related adverse events.
Balstilimab demonstrated meaningful and durable clinical activity, with manageable safety, in patients with previously-treated, recurrent/metastatic cervical cancer.
这项 II 期临床试验评估了抗 PD-1 抗体巴替利单抗（balstilimab）在先前治疗、复发/转移性宫颈癌患者中的安全性和抗肿瘤活性。
符合条件的患者为 18 岁或以上、复发和/或转移性宫颈癌患者，且在晚期疾病的先前铂类治疗方案后复发。巴替利单抗以 3mg/kg 的剂量静脉输注，每两周一次，最长 24 个月。主要终点是由独立审查委员会评估的客观缓解率（ORR，RECIST v1.1）。
数据截止时，161 名女性（中位年龄为 53 岁[范围为 25-81]）入组并接受了巴替利单抗治疗。其中，140 名患者基线时有可测量的疾病，且在转移性、持续性或复发性疾病中曾接受过一线铂类治疗；这些患者纳入疗效分析。ORR 为 15%（95%CI，10.0%-21.8%），包括 5 名完全缓解和 16 名部分缓解的患者。缓解持续时间的中位数为 15.4 个月。在 PD-L1 阳性肿瘤患者中，ORR 为 20%，但 PD-L1 阴性肿瘤患者也对巴替利单抗有反应（ORR，7.9%）。应答不限于鳞状细胞组织学肿瘤，在宫颈腺癌患者亚组中，ORR 为 12.5%。疾病控制率为 49.3%（95%CI，41.1%-57.5%）。免疫介导的肠炎（3.1%）和腹泻（1.9%）是最常见的 3 级或更高的治疗相关不良事件。
在先前治疗、复发/转移性宫颈癌患者中，巴替利单抗显示出有意义且持久的临床活性，安全性可管理。
