Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 11 of 27 o Number and percent of subjects with initiation of alternative therapy. • The 25th percentile, Median and 75th percentileand the maximum and minimum PFS at Week 8 , Week 24 and Overall and the corr esponding 95% CIs will be displayed. • PFS rate at Week 8,Week 24 and Overall and the corr esponding 95% CIs will be displayed. 7.5 Overall Survival ( OS) • The i nterval between t he date of first dose until the date of death or t he date of last follow- up will be calculated . • The OS rate , including the 95% CI, will be presented . Duration of follow- up will also be presented. OS will also be update d at yearly interv als during the Post Study Follow- up an d can be provided as addendums to the fi nal report. • Subjects who are still alive w ill be censored on the date of last follow-up. Eve ry effort will be made to follow subjec ts for OS after they dis continue the st udy. • OS will be summarized usi ng the 25th percenti le, Media n, and 75th percentile as well as the minimum and m aximum survival time, calc ulated by Kapla n-Meier method, and w ill be dis played gra phicall y 7.6 Duration of Response (DoR) • Dura tion of re sponse (DO R) will be calculated interval bet ween t he date o f earliest determinat ion of CR or PR to the da te of first PD, clinical progression or death whatever occurs first . Patients who had a respon se and did not lose it subsequently and were alive will be censored at the time of last available tumor assessment. • DOR in weeks = (Earlier of Date of PD or death – date of first response + 1) / 7 • The median DOR with 2 -sided 95% confidence intervals w ill be presented for subjects who have a confirmed CR or PR at 8 and 24 weeks. 7.7 Analysis of Time to Event (TTE) Variables Progression Free Survival (PFS), OS and DoR will be analyzed using the Kaplan- Meier product limit estimates along with the corresponding number of subjects at risk . The Duration of follow- up (in months) will be analyzed using the Reverse Kaplan- Meier product limit estimation method. For all time to event analys es the number of events, number censored, 25th percentile, median, 75th percentile, corresponding 95% CIs as well as the minimum and maximum survival time will be presented in tables. In addition, survival curves will be presented graphically. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 12 of 27 8.0 TRIAL DRUG EXPOSURE AND COMPLIANCE Extent of treatment exposure to durvalumab, will be assessed for each of the two study arms. Durvalumab exposure (Arms A and B) will be summarized by the following parameters: • Duration of durvalumab treatment (week), calculated as: (Last dose date – first dose date + 1) / 7 • Number of durvalumab doses • Total durvalumab dose (mg), defined as the sum of the actual doses (mg) administered • Number of subject s with durvalumab dose de- escalated (only in Arm A) Tremelimumab exposure (Arm B) will be summarized by the following parameters: • Duration of Tremelimumab treatment (week), calculated as: (Last dose date – first dose date + 1) / 7 • Number of tremelimumab doses • Total Tremelimumab dose (mg), defined as the sum of the actual doses (mg) administered BI 1361849 exposure (Arms A and B) will be summarized by the following parameters: • Duration of BI 1361849 treatment (week), calculated as: (Last dose date – first dose date + 1) / 7 • Number of doses • Total BI 1361849 dose ( µg), defined as the sum of the actual doses (mg) administered 9.0 SAFETY ANALYSIS 9.1 Adverse Events Adverse events (AEs) will be coded using MedDRA v20 or later and will be classified by System Organ Class (SOC) and preferred term (PT). Severity of AEs will be assessed according to CTCAE (v4.03).