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Updated: Dec 29, 2025
Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Neoadjuvant PD-1 inhibitor (Sintilimab) in NSCLC
Shugeng Gao1, Ning Li2, Shunyu Gao1
1Thoracic Surgery Department, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Introduction:
Programmed death receptor-1 (PD-1) inhibitors have shown efficacy in first-line treatment of NSCLC; however, evidence of PD-1 inhibitor as neoadjuvant treatment is limited. This is a phase 1b study to evaluate the safety and outcome of PD-1 inhibitor in neoadjuvant setting.
Methods:
Treatment-naive patients with resectable NSCLC (stage IA-IIIB) received two cycles of sintilimab (200 mg, intravenously, day 1 out of 22). Operation was performed between day 29 and 43. Positron emission tomography-computed tomography scans were obtained at baseline and before the operation. The primary end point was safety. Efficacy end points included rate of major pathologic response (MPR) and objective response rate. Expression of programmed cell death ligand 1 was also evaluated (registration number: ChiCTR-OIC-17013726).
Results:
A total of 40 patients enrolled, all of whom received two doses of sintilimab and 37 underwent radical resection. A total of 21 patients (52.5%) experienced neoadjuvant treatment-related adverse events (TRAEs). Four patients (10.0%) experienced grade 3 or higher neoadjuvant TRAEs, and one patient had grade 5 TRAE. Eight patients achieved radiological partial response, resulting in an objective response rate of 20.0%. Among 37 patients, 15 (40.5%) achieved MPR, including six (16.2%) with a pathologic complete response in primary tumor and three (8.1%) in lymph nodes as well. Squamous cell NSCLC exhibited superior response compared with adenocarcinoma (MPR: 48.4% versus 0%). Decrease of maximum standardized uptake values after sintilimab treatment correlated with pathologic remission (p < 0.00001). Baseline programmed cell death ligand 1 expression of stromal cells instead of tumor cells was correlated with pathologic regression (p = 0.0471).
Conclusions:
Neoadjuvant sintilimab was tolerable for patients with NSCLC, and 40.5% MPR rate is encouraging. The decrease of maximum standardized uptake values after sintilimab might predict pathologic response.
Insights
Neoadjuvant sintilimab showed acceptable safety and a 40.5% major pathologic response rate in non-small cell lung cancer (NSCLC) patients. Decreased SUVmax after treatment may predict pathologic response, offering a potential biomarker for neoadjuvant immunotherapy.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Programmed death receptor-1 (PD-1) inhibitors are effective in first-line non-small cell lung cancer (NSCLC) treatment.
- Limited evidence exists for PD-1 inhibitors as neoadjuvant therapy in NSCLC.
- This study addresses the safety and efficacy of neoadjuvant PD-1 inhibition.
Purpose of the Study:
- To evaluate the safety and outcomes of neoadjuvant sintilimab in patients with resectable NSCLC.
- To determine the rate of major pathologic response (MPR) and objective response rate (ORR).
- To explore potential predictive biomarkers for treatment response.
Main Methods:
- Phase 1b study enrolling treatment-naive patients with resectable NSCLC (Stage IA-IIIB).
- Two cycles of neoadjuvant sintilimab (200 mg) administered intravenously.
- Safety (adverse events) and efficacy (MPR, ORR) were primary endpoints; PET-CT and PD-L1 expression were assessed.
Main Results:
- 40 patients received sintilimab; 37 underwent resection.
- 52.5% experienced treatment-related adverse events (TRAEs), with 10.0% being Grade 3 or higher.
- ORR was 20.0%, MPR was 40.5% (higher in squamous cell NSCLC); decreased SUVmax and stromal PD-L1 expression correlated with response.
Conclusions:
- Neoadjuvant sintilimab is tolerable in NSCLC patients.
- The 40.5% MPR rate is encouraging for neoadjuvant immunotherapy.
- Decreased maximum standardized uptake values (SUVmax) post-treatment may predict pathologic response.
