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Poster Display session

84P - SHR-1316 vs placebo in combination with chemotherapy as perioperative treatment in patients with resectable stage II-III NSCLC: A randomized, double-blind, multicenter, phase 1b/3 trial


03 Apr 2022


Poster Display session


Tumour Site

Non-Small Cell Lung Cancer


Yi-Long Wu


Annals of Oncology (2022) 33 (suppl_2): S71-S78. 10.1016/annonc/annonc857


Y. Wu1, K. Chen2, W. Xing3, Q. Chen4, L. Liu5, Q. Zhang6, D. Ge7, Y. Liu8, X. Lin9, L. Wang9, Y. Huang9, W. Zhong8

Author affiliations

  • 1 Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital & Guangdong Academy of Medical Sciences, 510080 - Guangzhou/CN
  • 2 Beijing Cancer Hospital, Beijing/CN
  • 3 The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou/CN
  • 4 Zhejiang Cancer Hospital, Hangzhou/CN
  • 5 West China Hospital of Sichuan University, Chengdu/CN
  • 6 Jiangsu Cancer Hospital, Nanjing/CN
  • 7 Zhongshan Hospital Fudan University, Shanghai/CN
  • 8 Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou/CN
  • 9 Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai/CN

Abstract 84P


SHR-1316 is a humanized IgG4 monoclonal PD-L1 antibody which has shown promising antitumor activity in solid tumors. This phase 1b/3 trial evaluates the efficacy and safety of SHR-1316 plus chemotherapy vs placebo plus chemotherapy as perioperative treatment for resectable NSCLC. Here, we reported the results from the phase 1b study.


Eligible patients were resectable stage II and III (IIIA and T3N2M0 IIIB) NSCLCs without EGFR/ALK alterations. Patients received neoadjuvant treatment with 3 cycles of intravenous SHR-1316 (20 mg/kg on day 1), nab-paclitaxel (100 mg/m2 on days 1, 8, and 15), and carboplatin (area under the curve 5, 5 mg/mL per min on day 1), of each 21-day cycle, followed by surgical resection. After that, patients further received 16 cycles of SHR-1316 (20 mg/kg on day 1) adjuvant treatment. The primary endpoint was major pathological response (MPR) per blinded independent pathological review (BIPR), defined as ≤10% viable tumor cells in resection specimen. If MPR was >55% then phase 3 trial will be initiated.


From Jul 14, 2020 to May 12, 2021, 37 patients received SHR-1316 plus chemotherapy neoadjuvant treatment and 34 patients underwent surgery. As of data cutoff on Nov 26, 2021, 19 (55.9%, 95% CI 39.5-71.1) of the 34 patients underwent surgery achieved MPR per BIPR and 11 (32.4%, 95% CI 19.1-49.2) patients achieved pathological complete response. Of the 37 patients received neoadjuvant treatment, 26 (70.3%, 95% CI 54.2-82.5) patients had an objective response per RECIST v1.1, including 1 with complete response and 25 with partial response. Treatment-related adverse events (AEs) were reported in 37 (100%) patients. 29 (78.4%) patients had grade ≥3 treatment-related AEs and 9 (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 6 (17.6%) of the 34 patients.


SHR-1316 in combination with nab-paclitaxel and carboplatin as neoadjuvant therapy showed a high proportion of MPR in resectable NSCLC, and the safety profile was well tolerated. Based on the phase 1b results, the phase 3 trial was initiated and ongoing.

Clinical trial identification


Legal entity responsible for the study

Jiangsu Hengrui Pharmaceuticals Co., Ltd.


Jiangsu Hengrui Pharmaceuticals Co., Ltd.


X. Lin, L. Wang, Y. Huang: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.

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