在晚期皮肤鳞状细胞癌的 2 期研究中进行的综合分析：结果的扩展随访和生活质量分析。

Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis.

机构信息

Department of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia

Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.

出版信息

J Immunother Cancer. 2021 Aug;9(8). doi: 10.1136/jitc-2021-002757.

BACKGROUND

To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).

METHODS

Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks).

RESULTS

Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001).

CONCLUSIONS

This is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.

背景

提供了 3 项 2 期研究中接受西普单抗治疗的晚期皮肤鳞状细胞癌（CSCC）患者的长期数据汇总，并确定了缓解持续时间（DOR）和对生活质量（QoL）的影响。

方法

患者接受西普单抗 3mg/kg，每 2 周（第 1 组：转移性 CSCC[mCSCC]，n=59；第 2 组：局部晚期 CSCC，n=78）或西普单抗 350mg，每 3 周（第 3 组：mCSCC，n=56）。主要终点是独立中央审查（ICR）的客观缓解率（ORR）。在每个治疗周期的第 1 天（第 1 组和第 2 组：8 周；第 3 组：9 周）反复测量 QoL。

结果

中位随访时间为 15.7 个月。总体而言，ICR 的 ORR 为 46.1%（95%CI：38.9%至 53.4%）。第 1、2 和 3 组的完全缓解（CR）率分别为 20.3%、12.8%和 16.1%。CR 的中位时间为 11.2 个月。在部分缓解或 CR 的患者中，首次客观缓解后 12 个月时持续缓解的估计比例为 87.8%（95%CI：78.5%至 93.3%），中位 DOR 尚未达到。Kaplan-Meier 估计的总生存期（OS）概率为 24 个月时的 73.3%（95%CI：66.1%至 79.2%），中位 OS 尚未达到。早在第 2 周期就观察到总体健康状况（GHS）/QoL 改善，且一直显著改善并持续至最后一次评估。疼痛首次临床意义上的改善的 Kaplan-Meier 估计中位时间为 2.1（95%CI：2.0 至 3.7）个月，在应答者与无应答者之间差异有统计学意义（p<0.0001）。