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Three-Year Follow-Up of Neoadjuvant Programmed Cell Death Protein-1 Inhibitor (Sintilimab) in NSCLC
Fan Zhang1, Wei Guo2, Bolun Zhou1
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 cell death protein-1 (PD-1) inhibitors have been proved to be feasible and to have efficacy in multiple cancers, including NSCLC. But few studies have evaluated the effectiveness of PD-1 inhibitor as neoadjuvant therapy with a long-term follow-up. Here, in this phase 1b study with a 3-year follow-up, we reported the clinical outcomes of patients who received the PD-1 inhibitor as neoadjuvant therapy.
Methods:
Two doses of sintilimab (intravenously, 200 mg) were used for patients with stages IA to IIIB NSCLC (registration number: ChiCTR-OIC-17013726). Then, surgery was performed within 29 to 43 days after the first dose. All patients underwent positron emission tomography-computed tomography at enrolment and before surgery to evaluate tumor metabolism after administration of PD-1 inhibitor. We also evaluated the expression of programmed death-ligand 1 (PD-L1) as an exploratory analysis in 32 eligible patients. Safety was the primary end point. Overall survival (OS), disease-free survival (DFS), event-free survival, and major pathologic response were the key secondary end points.
Results:
With the mean follow-up of 37.8 months, 3-year OS rate was 88.5% and the 3-year DFS rate was 75.0% among patients who underwent R0 resection. In patients with positive PD-L1 expression, 3-year OS and DFS rates were 95.5% and 81.8%, respectively. Eight patients had recurrent tumors, including local recurrence, lung metastasis, brain metastasis, and bone metastasis. Patients with PD-L1 greater than or equal to 1% had more favorable clinical outcomes than the other subgroup (hazard ratio = 0.275, 95% confidence interval: 0.078-0.976). No more new adverse events have occurred in the 3-year follow-up because we first reported them in the former publication.
Conclusions:
This is the first study to report the long-term survival probability of patients with NSCLC receiving PD-1 inhibitors as the neoadjuvant treatment. The 3-year follow-up results revealed that patients with positive PD-L1 expression and high tumor mutation burden have favorable clinical outcomes.
Insights
This phase 1b study shows that neoadjuvant programmed cell death protein-1 (PD-1) inhibitor therapy offers promising long-term survival for non-small cell lung cancer (NSCLC) patients. Positive PD-L1 expression correlates with improved outcomes, highlighting its predictive value.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Programmed cell death protein-1 (PD-1) inhibitors demonstrate efficacy in various cancers, including non-small cell lung cancer (NSCLC).
- Limited data exists on the long-term effectiveness of PD-1 inhibitors used as neoadjuvant therapy for NSCLC.
Purpose of the Study:
- To report the 3-year clinical outcomes of NSCLC patients treated with neoadjuvant PD-1 inhibitor therapy.
- To evaluate the safety and efficacy of sintilimab as neoadjuvant treatment for NSCLC.
Main Methods:
- A phase 1b study involving patients with stages IA to IIIB NSCLC receiving two doses of sintilimab (200 mg intravenously).
- Surgery was performed 29-43 days post-initial dose, with PET-CT scans for tumor metabolism assessment.
- Exploratory analysis of programmed death-ligand 1 (PD-L1) expression was conducted in 32 eligible patients.
Main Results:
- With a mean follow-up of 37.8 months, 3-year overall survival (OS) was 88.5% and disease-free survival (DFS) was 75.0% in patients achieving R0 resection.
- Patients with positive PD-L1 expression showed higher 3-year OS (95.5%) and DFS (81.8%).
- Favorable clinical outcomes were observed in patients with PD-L1 expression >= 1% (hazard ratio = 0.275).
Conclusions:
- This study provides the first long-term survival data for NSCLC patients receiving neoadjuvant PD-1 inhibitors.
- Positive PD-L1 expression and high tumor mutation burden are associated with favorable clinical outcomes in this cohort.
- Neoadjuvant PD-1 inhibitor therapy demonstrates durable efficacy and an acceptable safety profile in NSCLC.
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