In a phase 2 clinical trial, 107 patients with unresectable stage III NSCLC were treated with neoadjuvant SHR-1701 (a PD-L1-targeting antibody fused with extracellular domain of the TGFβII receptor) with (n=97) or without chemotherapy (n=10). At a median follow-up of 22.2 months, 56% of patients had a response (1% complete response), with an 18-month event-free survival (EFS) rate of 58.3%. While most patients went on to receive radiotherapy, 25% achieved surgical resectability and underwent successful complete resections, with 44% major pathological responses, 26% pathological complete responses, and an 18-month EFS rate of 74.1%.
Contributed by Lauren Hitchings
ABSTRACT: 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 (n = 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.
Author Info: (1) Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China. (2) Guang
Author Info: (1) Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China. (2) Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China. (3) Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China. (4) Department of Respiratory Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, China. (5) Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430079, China. (6) Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300060, China. (7) Department of Lung Cancer, Tianjin Medical University Cancer Institute & Hospital, Tianjin 300060, China. (8) 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. (9) Department of Medical Oncology, The First Affiliated Hospital of Henan University of Science & Technology, Luoyang 471000, China. (10) Department of Chest Radiotherapy, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410000, China. (11) Department of Respiratory Medicine, Shanxi Provincial Cancer Hospital, Taiyuan 030013, China. (12) First Ward of Respiratory Medicine, Harbin Medical University Cancer Hospital, Harbin 150000, China. (13) Department of Thoracic Surgery, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou 310022, China. (14) Department of Thoracic Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou 310022, China. (15) Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China. (16) Department of Thoracic Radiotherapy, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan 250017, China. (17) Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming 650000, China. (18) Jiangsu Hengrui Pharmaceuticals, Co., Ltd, Shanghai 201203, China. (19) Jiangsu Hengrui Pharmaceuticals, Co., Ltd, Shanghai 201203, China. (20) Jiangsu Hengrui Pharmaceuticals, Co., Ltd, Shanghai 201203, China. (21) Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou 510000, China. Electronic address: syylwu@live.cn.
