Planned Study Analyses 7.4.1. Statistical Summaries: Descriptive and Inferential All statistical tests will be two -sided and a difference resulting in a p -value of less than or equal to 0.05 will be considered statistically significant (although possibly of exploratory nature) . All p -values will be rounded to and displayed in four decim als. If a p -value less than 0.0001 occurs it will be shown in tables as <0.0001. OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 25/51 Descriptive summaries of variables will be provided where appropriate. For continuous variables, the number of non -missing values (n) , mean, standard deviation, median, minimum, and maximum will be tabulated by treatment. For categorical variables, the counts and proportions of each value will be tabulated by treatment . Expansion of descriptive table categories within each treatment may occur if such elaborations are though t to be useful. All study related data collected will be presented in listings. Study related d ata not subject to analysis according to this plan will not appear in any tables or graphs but will be included in the data listings. 7.4.2. Interim Analyses and Data Monitoring No interim analysis of the primary endpoint was planned. However, OS rate at 12 months w as to be analyzed on Arm A at end of Step 1 before a decision to stop or continue enrollment in Step 2 c ould be made by the Steering Committee after recommendation by the IDMC. This analysis was considered as a futility analysis. Consequently, no adjustment for multiplicity (as combination test for example) was considered for the primary analysis of step 2. The enrolment stop because of the foreseen impact of the COVID -19 pandemic on the primary endpoint of the step 2 was not planned. 7.4.3. Final Analysis and Publication of Study Results This analysis (cut-off date : 15 January 2021 - 219 post ICI patients ) is considere d as an update of the step 1 analysis. This CSR will be comple mented by an addendum with th is analysis . OSE Immunotherapeutics v2.2 Study OSE2101C301 (ATALANTE 1) Statistical Analysis Plan 2021 -07-23 IND#: BB-IND 10802 CONFIDENTIAL P a g e | 26/51 8. SUMMARY OF STUDY DATA All the analyses described in this section will be duplicate in the population of interest and in the overall population.