Final Analysis of Neoadjuvant Sintilimab Plus Chemotherapy in IB-IIIA Non-Small-Cell Lung Cancer: Phase 2 neoSCORE Trial.

The optimal number of neoadjuvant chemoimmunotherapy cycles for resectable non-small cell lung cancer (NSCLC) remains uncertain. The randomized phase 2 neoSCORE trial (NCT04459611) conducted a comprehensive final analysis, comparing the outcomes of two versus three cycles of neoadjuvant sintilimab combined with platinum-doublet chemotherapy in 60 stage IB-IIIA NSCLC patients, among whom 55 underwent surgery. After a median follow-up period of 56.9 months, no statistically significant differences in disease-free survival (DFS) or overall survival (OS) were observed between the two-cycle and three-cycle groups. Specifically, the 4-year DFS rates stood at 53.8% and 55.2% while the 4-year OS rates were 76.9% and 75.9%, respectively. Major pathological response (MPR) was strongly associated with improved DFS (HR = 0.26, 95% CI: 0.08-0.85, p = 0.026) and OS (HR = 0.15, 95% CI: 0.03-0.81, p = 0.028) on multivariable Cox analysis. Exploratory analysis revealed that maintenance immunotherapy was associated with longer DFS among patients who achieved MPR, whereas no clear DFS or OS advantage was observed among patients without MPR. In summary, no superiority of three cycles over two cycles was demonstrated in this study. MPR stands out as an independent prognostic indicator, and maintenance immunotherapy seems to be associated with long-term prognosis in patients who achieved MPR, necessitating further prospective validation. Trial Registration: ClinicalTrials.gov identifier: NCT04459611.