Statistical analysis
PD
The full analysis set included all patients enrolled in the study. The safety set included all patients who received at least one dose of QL1706. The PK analysis set consisted of patients in the safety set and had at least one evaluable PK sample. Efficacy analyses were those with at least one post-treatment image in the safety population. The data cutoff for this report was 2021-12-31. The ORR and DCR were calculated using the exact method. We calculated the DoR with the Kaplan–Meier method; median values and 95% confidence intervals (CIs) were calculated by the Brookmeyer–Crowley method. Comparisons between predose and postdose (cycle 1, 168 h) values for certain PD markers were made using the Wilcoxon signed-rank test. The analyses of demographics, safety, and tolerability were descriptive.