2 CHANGES TO THE FINAL SAP 2.1 Survival Assessments These changes relate to section 6.2 of the final SAP. As well as the previously planned derivation of DFS1, DFS2, OS1 and OS2 in weeks, these survival endpoints will also be derived in months. All DFS1, DFS2, OS1 and OS2 summaries and graphical presentations will be repeated in months. The listing of the survival data will include survival times in months. For DFS1 and DFS2, survival rates and 95% confidence interval at 1, 2 and 3 years will not be presented. Instead, the number of patients who progressed at ≤ 1 year and at ≤ 2 years will be presented. For OS1 and OS2, where survival rate is not calculated at 2 (or more) years due to there being no patient deaths, the survival rate for the previous year will be displayed instead. The number of patients left at risk out of all patients in the group will be presented along with the survival rates. Reason for the change The addition of summaries in months will help with the interpretation of the results. Survival rates for DFS1 and DFS2 are not presented due to lack of dat a. OS1 and OS2 rates of the previous year will be presented as the current year’s rate in the case described above to aid interpretation of the data. 2.2 Relationship between resection surgery outcome and survival endpoints This change relates to section 6.3 of the final SAP. Relationship between resection surgery outcome and survival endpoints will be investigated. The summaries of DFS1, DFS2, OS1 and OS2 in weeks and months will be presented by resection surgery outcome (R0/R1) for the all treated patient (ATP) analysis set. These summaries will also be presented graphically using a Kaplan- Meier plot and a swimmer plot. Reason for the change This change explores a possible relationship between resection surgery outcome and survival endpoints. Syne qua non study no: TAX12001 Targovax study no: CT TG01 -01 Page 5 of 5 Date: 04OCT2018 Version: Final 1.0 ST/form/038/1 2.3 Immune Response This change relates to section 6.1. of the final SAP. Definition of an immune response to GM-CSF/TG01 is updated to include the following condition: Patients who have a positive immune response at Day 1 only and have no positive responses at any other visits will be excluded from both “initial treatment phase” and “over entire study course”. Reason for the change This change was for clarification purposes. 2.4 Positive T -cell Responders This change relates to section 6.1 of the final SAP. Chemotherapy visits will also be considered in the derivation of positive T -cell responders.