Statistical analyses
death, tumor, ®, toxicity, nonsquamous NSCLC
REGRESSION, TUMOR, RECURRENT DISEASE
A total of 632 patients were planned to be enrolled in this study. The intention‐to‐treat (ITT) population included all randomized patients based on the intended treatment arm, regardless of treatment received. The per‐protocol (PP) population included patients in either treatment arm who had received either at least three cycles of their allocated treatment, or less than three cycles of treatment (due to early progression, death, or excessive toxicity), along with one tumor assessment and no major protocol deviations that could significantly impact on efficacy or safety outcomes. Patients who discontinued prior to week 18 for any reason were counted as nonresponders in the primary endpoint analysis for the ITT population. Efficacy analyses were carried out in both the ITT and PP populations. Safety analyses were carried out in the safety population, which included all randomized patients who received at least one dose of BAT1706 or EU‐bevacizumab, and who were assigned to that treatment.For the primary endpoint, the risk ratio of and the risk difference between the treatment arms for ORRFor time‐to‐event variables such as PFS, OS, and DoR, Kaplan–Meier curves were calculated and displayed. A stratified Cox regression model yielded estimated hazard ratios (HRs) with 95% CIs, with treatment as the explanatory variable, and nonsquamous NSCLC stage (recurrent disease or Stage IV), sex (male or female), and ethnicity (Asian or non‐Asian) as stratification factors; an HR <1.0 favored BAT1706. Statistical analyses were carried out using SAS Version 9.4®. PK parameters were analyzed using Phoenix® WinNonlin® Version 8.0, with PK figures generated using SAS Version 9.4®.