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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.
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.
