Statistical assessments
PD, tumor
TUMOR
Assuming a targeted ORR of 20%, a total of 109 patients could provide 90% confidence in the unilateral 5% alpha level to prove that Pucotenlimab is superior to the historical control of 10% [The full analysis set (FAS) included all the patients who were administrated with at least one dose of Pucotenlimab. Efficacy and Safety analysis will be conducted based on FAS. ORR and DCR with 95% CI were calculated using the Clopper–Pearson exact method based on binomial distribution. Patients without tumor assessment data were considered as non-respond or rather, PD. Kaplan–Meier method was used to estimate median DOR and PFS, and their 95% CIs were estimated by Brookmeyer-Crowley method. Safety was analyzed using descriptive statistics. Data analyses were conducted using SAS statistical software version 9.4 and MedCalc Version 20.2.