2. Academic Validation
  3. Adebrelimab (SHR-1316) in combination with chemotherapy as perioperative treatment in patients with resectable stage II-III NSCLC: an open-label, multicenter, phase 1b trial

Adebrelimab (SHR-1316) in combination with chemotherapy as perioperative treatment in patients with resectable stage II-III NSCLC: an open-label, multicenter, phase 1b trial

  • J Thorac Oncol. 2022 Sep 30;S1556-0864(22)01822-6. doi: 10.1016/j.jtho.2022.09.222.
Wanpu Yan 1,  Wen-Zhao Zhong 2,  Yan-Hui Liu 2,  Qixun Chen 3,  Wenqun Xing 4,  Qin Zhang 5,  Lunxu Liu 6,  Di Ge 7,  Keneng Chen 1,  Fan Yang 8,  Xiang Lin 9,  Li Song 9,  Wei Shi 9,  Yi-Long Wu 10
Affiliations

Affiliations

  • 1 Department of Thoracic Oncology I, Beijing Cancer Hospital, Beijing, China.
  • 2 Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.
  • 3 Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.
  • 4 Thoracic Surgery Ward, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
  • 5 Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, China.
  • 6 Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China.
  • 7 Thoracic Surgery, Zhongshan Hospital Fudan University, Shanghai, China.
  • 8 Thoracic Surgery, Peking University People's Hospital, Beijing, China.
  • 9 Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China.
  • 10 Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: [email protected].
PMID: 36191882 DOI: 10.1016/j.jtho.2022.09.222
Abstract

Introduction: This study evaluated adebrelimab (a PD-L1 antibody) plus nab-paclitaxel and carboplatin as perioperative treatment for resectable NSCLC.

Methods: Eligible patients had resectable stage II-III NSCLCs without driver gene. Patients received neoadjuvant treatment with 3 cycles of intravenous adebrelimab (20 mg/kg on day 1), nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), and carboplatin (area under the curve 5 mg/mL per min on day 1), of each 21-day cycle before surgical resection, and followed by 16 cycles of adebrelimab (20 mg/kg on day 1 in 3 weeks) adjuvant treatment. The primary endpoint was major pathological response (MPR) per blinded independent pathological review (BIPR).

Results: A total of 37 patients were enrolled and received planned neoadjuvant therapy. Thirty-four (91.9%) patients underwent surgery. As of data cutoff on Jan 25, 2022, 19 (51.4%, 95% CI 35.9-66.6) of the 37 patients achieved MPR per BIPR and 11 (29.7%, 95% CI 17.5-45.8) patients achieved pathological complete response. Twenty-six (70.3%, 95% CI 54.2-82.5) patients had an objective response per RECIST v1.1. The 12-month event-free survival (EFS) rate was 77.8% (95% CI 54.1-90.3). Twenty-nine (78.4%) patients had grade ≥3 treatment-related adverse events (AEs) and nine (24.3%) had treatment-related serious AEs. No treatment-related deaths occurred. Grade ≥3 surgery-related AEs within 30 or 90 days after surgery were both reported in 5 (14.7%) patients.

Conclusion: Adebrelimab plus nab-paclitaxel and carboplatin as perioperative therapy led to a substantial proportion of MPR and high resectability, with manageable toxicities. Based on the phase 1b results, phase 3 trial was initiated.

Keywords

Adebrelimab; NSCLC; perioperative therapy.

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