Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial,Cancer Cell

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Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial
Cancer Cell ( IF 48.8 ) Pub Date : 2024-06-20 , DOI: 10.1016/j.ccell.2024.05.024
Qing Zhou ₁ , Yi Pan ₁ , Xuening Yang ₁ , Yanqiu Zhao ₂ , Guang Han ₃ , Qingsong Pang ₄ , Zhenfa Zhang ₅ , Qifeng Wang ₆ , Jun Yao ₇ , Hui Wang ₈ , Weihua Yang ₉ , Baogang Liu ₁₀ , Qixun Chen ₁₁ , Xianghui Du ₁₂ , Kaican Cai ₁₃ , Baosheng Li ₁₄ , Yunchao Huang ₁₅ , Xiao Li ₁₆ , Li Song ₁₆ , Wei Shi ₁₆ , Yi-Long Wu ₁

Affiliation

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China.
Department of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, China.
Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430079, China.
Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300060, China.
Department of Lung Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300060, China.
Radiotherapy Center, Radiation Oncology Key Laboratory of Sichuan Province, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu 610000, China.
Department of Medical Oncology, The First Affiliated Hospital of Henan University of Science & Technology, Luoyang 471000, China.
Department of Chest Radiotherapy, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410000, China.
Department of Respiratory Medicine, Shanxi Provincial Cancer Hospital, Taiyuan 030013, China.
First Ward of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin 150000, China.
Department of Thoracic Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou 310022, China.
Department of Thoracic Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou 310022, China.
Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
Department of Thoracic Radiotherapy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250017, China.
Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming 650000, China.
Jiangsu Hengrui Pharmaceuticals, Co., Ltd, Shanghai 201203, China.

We conducted a proof-of-concept, phase 2 trial to assess neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy, and then consolidation SHR-1701 in unresectable stage III non-small-cell lung cancer (NSCLC). In the primary cohort of patients receiving neoadjuvant combination therapy ( = 97), both primary endpoints were met, with a post-induction objective response rate of 58% (95% confidence interval [CI] 47–68) and an 18-month event-free survival (EFS) rate of 56.6% (95% CI 45.2–66.5). Overall, 27 (25%) patients underwent surgery; all achieved R0 resection. Among them, 12 (44%) major pathological responses and seven (26%) pathological complete responses were recorded. The 18-month EFS rate was 74.1% (95% CI 53.2–86.7) in surgical patients and 57.3% (43.0–69.3) in radiotherapy-treated patients. Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes.

中文翻译：

新辅助 SHR-1701 联合或不联合化疗治疗不可切除的 III 期非小细胞肺癌：概念验证 2 期试验

我们进行了一项概念验证、2 期试验，以评估新辅助 SHR-1701 联合或不联合化疗、随后进行手术或放疗，然后巩固 SHR-1701 治疗不可切除的 III 期非小细胞肺癌 (NSCLC)。在接受新辅助联合治疗的主要患者队列中 (= 97)，两个主要终点均得到满足，诱导后客观缓解率为 58%（95% 置信区间 [CI] 47-68），事件发生时间为 18 个月- 无生存率 (EFS) 为 56.6% (95% CI 45.2–66.5)。总体而言，27 名 (25%) 患者接受了手术；全部实现R0切除。其中，记录了 12 例（44%）主要病理反应和 7 例（26%）病理完全反应。手术患者的 18 个月 EFS 率为 74.1% (95% CI 53.2–86.7)，而放疗患者的 18 个月 EFS 率为 57.3% (43.0–69.3)。新辅助 SHR-1701 联合化疗，随后进行手术或放疗，在不可切除的 III 期 NSCLC 中显示出良好的疗效和可耐受的安全性。手术转换对于相当大比例的患者是可行的，并且与更好的生存结果相关。

更新日期：2024-06-20

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