Five-Year Clinical Outcomes after Neoadjuvant Nivolumab in Resectable Non-Small Cell Lung Cancer

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Neoadjuvant anti-PD-1 therapy is a promising approach for resectable non-small cell lung cancer (NSCLC).
• Previous studies indicated safety and feasibility of neoadjuvant nivolumab with encouraging pathological responses.
• Long-term clinical outcomes are crucial for evaluating the efficacy of novel cancer treatments.

Purpose of the Study:

• To present the 5-year clinical outcomes of a phase I/II trial investigating neoadjuvant nivolumab in resectable NSCLC.
• To assess the long-term recurrence-free survival (RFS) and overall survival (OS) rates.
• To explore the association of major pathological response (MPR) and PD-L1 expression with survival outcomes.

Main Methods:

• Twenty-one patients with Stage I-IIIA NSCLC received neoadjuvant nivolumab (3 mg/kg) for 4 weeks pre-surgery.
• Evaluated 5-year RFS, OS, and correlations with MPR and pre-treatment tumor PD-L1 positivity (TPS ≥1%).
• Median follow-up was 63 months.

Main Results:

• Five-year RFS and OS rates were 60% and 80%, respectively.
• Patients achieving MPR (89%) showed no cancer-related deaths and remained disease-free at 5 years.
• MPR and PD-L1 positivity trended towards favorable RFS, though statistical significance was limited by sample size.

Conclusions:

• Five-year clinical outcomes for neoadjuvant nivolumab in resectable NSCLC are favorable compared to historical data.
• MPR and PD-L1 positivity appear to be associated with improved RFS, warranting further investigation.
• This study provides the longest follow-up data for neoadjuvant anti-PD-1 therapy in any cancer type.