Efficacy and Safety of Atezolizumab in Chinese Patients With Advanced Thymic Carcinoma: A Multicenter, Single-Arm Phase 2 Study

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical lung cancer Pub Date : 2025-01-29 DOI:10.1016/j.cllc.2025.01.011

Shun Lu , Xuezhen Ma , Lunxu Liu , Qiang Li , Jian Hu , Changli Wang , Jianxing He , Xiufeng Hu , Chun Chen , Zhenzhou Yang , Dandan Hu , Yanjun Shi , Yi Zhou , Mo Chen

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Abstract

Introduction

There are limited treatment options for thymic carcinoma. This study aimed to evaluate the efficacy and safety of atezolizumab for the treatment of advanced thymic carcinoma after failure with prior systemic therapy.

Patients and Methods

Patients aged ≥ 18 years with advanced thymic carcinoma after failure with prior systemic therapy were enrolled at 10 medical centers in China. Atezolizumab 1200 mg was administered on Day 1 (baseline) every 3 weeks until unacceptable toxicity/loss of clinical benefit. The primary efficacy endpoint was the confirmed objective response rate in the full analysis set.

Results

Between 29 July 2020 and 28 December 2022, 34 patients enrolled (median age, 54.5 years), and 16 (47.1%) had received ≥ 2 prior lines of therapy. At the cut-off date (July 16, 2023), the median follow-up duration was 19.1 months. The confirmed objective response rate (ORR) was 14.7% (95% confidence interval, 5.0%-31.1%); disease control rate, 58.8%; median progression-free survival (PFS), 3.2 months; 24-month OS rate, 63.2%; Better ORR and PFS were observed in PD-L1-positive patients versus PD-L1-negative patients (40.0% vs. 0% and 7.4 vs. 1.5 months, respectively). No correlation was observed with TMB. The incidence of adverse events (AEs) was 94.1%; serious AEs, 26.5%; immune-related AEs, 29.4%; and AEs leading to drug withdrawal, 2.9%.

Conclusions

In patients with advanced thymic carcinoma who had failed prior systemic therapy, atezolizumab was well-tolerated with a manageable toxicity profile and showed encouraging the antitumor activity, especially in patients with PD-L1-positive tumors.

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Atezolizumab在中国晚期胸腺癌患者中的疗效和安全性：一项多中心、单组2期研究

胸腺癌的治疗选择有限。本研究旨在评估atezolizumab治疗既往全身治疗失败的晚期胸腺癌的疗效和安全性。患者和方法：年龄≥18岁，既往全身治疗失败的晚期胸腺癌患者纳入中国10个医疗中心。在第1天（基线）每3周给予Atezolizumab 1200mg，直到不可接受的毒性/丧失临床益处。主要疗效终点是整个分析集中确定的客观有效率。结果：在2020年7月29日至2022年12月28日期间，入组的34例患者（中位年龄54.5岁），16例（47.1%）接受过≥2条既往治疗。截止日期（2023年7月16日），中位随访时间为19.1个月。确诊客观有效率（ORR）为14.7%(95%可信区间5.0% ~ 31.1%)；疾病控制率58.8%；中位无进展生存期（PFS）， 3.2个月；24个月OS率63.2%；pd - l1阳性患者的ORR和PFS优于pd - l1阴性患者（分别为40.0%对0%和7.4个月对1.5个月）。与TMB无相关性。不良事件（ae）发生率为94.1%；严重ae占26.5%；免疫相关ae， 29.4%；ae导致停药，占2.9%。结论：在既往全身治疗失败的晚期胸腺癌患者中，atezolizumab耐受性良好，毒性可控，并显示出令人鼓舞的抗肿瘤活性，特别是在pd - l1阳性肿瘤患者中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical lung cancer 医学-肿瘤学

CiteScore

7.00

自引率

2.80%

发文量

159

审稿时长

24 days

期刊介绍： Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.