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
  • 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.
Products