CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 8 of 27 Subject disposition data will also be presented in data listings. 6.0 DEMOGRAPHIC AND BASELINE CHARACTERISTICS 6.1 Demographic Characteristics Demogra phic and base line char acteristics at study entry ( Screening/baseline visit which will occur up to one month before start of treatment) will be summar ized for the ITT and PP Popula tions. Demographic and baseline variables to be summarized include: • Continuous variables - Age (years) at time of consent - Height (cm) at screening - Weight (kg) at screening - Body mass index (BMI) (kg/m2) at screening • Categorical variables - Gender - Race - Ethnicity Demographic and baseline characteristics by subject will be presented in a table and data listings. 6.2 Medical History Medical History was collected at the Screening/Baseline visit. Medi cal history, including any ongoing and signif icant conditions or dis eases that stopped at or prior to informed consent, must be elicited from e ach subject during sc reening. The medi cal history shall include a complete review o f systems, past medical and su rgical histo ries, and any a llergies. The frequency count and percentage of subjects experiencing any medical conditions will be tabulated by system organ classifications (SOC) and preferred term (PT). If a preferred term or system organ class was reported more than once for a subject , the subject would only be counted once in the incide nce for that preferred term or system organ class. Medical history data will also be listed for Safety Population. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 9 of 27 6.3 Prior and Concomitant Medication s and Procedures Prior medications and procedures include any medic ation or non-drug therapy or procedure taken or performed w ithin 30 days prior to sc reening a nd before the fir st dose of study drug. Prior medi cations w ill be coded using the Wor ld Health Organiza tion Drug Dic tionary [10]. Concomitant medications are all medi cations, other than the study drug, taken on or af ter the fir st day of st udy drug dos e through 30 days after end of treatment. Concomitant medi cations and procedures will be coded using the Wor ld Health Organiza tion Drug Dic tionary. Medications that started before the first dose of study drug and were ongoing on the date of the first dose will be considered concomitant medications. The number and proportion of the subjects who took each medication, or had qualifying concomitant procedures, will be tabulated by the ATC-2 level and preferred name for concomitant medications. A subject will only be counted once within each ATC-2 code and within each preferred name. Prior and concomitant medications will also be listed for ITT. 7.0 EFFICACY ANALYSIS Tumor Response w ill be summ arized and anal yzed de scriptively for e ach a rm for the ITT and P P populations . 7.1 R esponse Rate • Responses at Week 8 and Week 24 will be presented . The Number and Percent of subjects in each category (Complete Response, Partial Response, Stable Disease, Progressive Disease or Not Evaluable) will be presented . • Best Overall Response (BOR) will also be presented. In the determination of BOR, any subsequent scans on or after the date of a clinical progressi on will be ignored. 7.2 Objective Response Rate (ORR) • Objective Response Rate (ORR) is defined as the percentage of subjects meeting criteria of Complete Response (CR) or Partial Response (PR). • To be assigned a status of a CR or PR , changes in tumor measurements m ust be confirmed by repeat asse ssments that must be perf ormed at l east 4 weeks after the cr iteria for response are first met. If a response is not confirmed, it is considered stable disease. • If a subject had clinical progression (CP) , any recorded response (CR or PR) after the date of CP will be considered invalid. Sponsor: Ludwig Institute for Cancer Research. Protocol Number: LUD2014- 012-VAC. CONFIDENTIAL SAP Version: 3.0 Effective Date: 09DEC2020 Page 10 of 27 • Subjects who drop out prior to having a response assessment (including clinical progression) for ORR will be consi dered as non-responders and they w ill be included in the denominator when ca lcula ting the propor tion. • A 95% Confi dence Interval based on binom ial distribution w ill be constr ucted for t he estimated ORR at 8 and 24 we eks. 7.3 Disease Control Rate (DCR) • Disease Control Rate (DCR) is defined as the percent of subjects with Stable Disease (SD), Partial Response (PR) and Complete Response (CR). • Subjects who drop out prior to mee ting the responde r criteria for DCR w ill be consi dered as non-responde rs. • A 95% Confi dence Interval based on binom ial distribution w ill be constr ucted for t he estimated DCR at 8 and 24 weeks. 7.4 P rogression -free Survival (PFS) • PFS is the inte rval bet ween t he date of first dose to the date of e arliest determinat ion of Progre ssive D isease (PD) (including clinical progression), or to the da te of de ath, if PD does not occur. • Subjects w ithout documentat ion of progression at the time of t he anal ysis w ill be censored at the date of last res ponse assessment. • Subjects with no tumor res ponse ass essment will be censored at the st art date of t he treatment. • Subjects who disc ontinued tre atment or w ithdrew from the st udy for reas ons other than documented PD (including clinical progression) or d eath will be censored at the date of last response ass essment pri or to discontinuati on or withdra wal. Descriptive analyses of PFS, at Week 8, Week 24 and Overall, will include the following: • Number and percentage of subjects that died or had a progressive disease or clinical progression, • Number and percentage of subjects censored: o Number and percentage of subjects lost to follow up (unknown survival and/or progression status) o Number and percent of subjects survived without progression o Number and percentage of subjects missing tumor response assessment. Sponsor: Ludwig Institute for Cancer Research.