36 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 6 / 36 LIST OF ABBREVIATIONS AE Adverse event ALT Alanine transaminase (SGPT) ANC Absolute neutrophil count AST Aspartate transaminase (SGOT) ATC Anatomical therapeutic chemical classification BUN Blood urea nitrogen BMI Body mass index CI Confidence interva l CR Complete response CRF Case report form CT Computed tomography CTCAE Common terminology criteria for adverse events DMC Data monitoring committee eCRF Electronic case report form ECOG Eastern cooperative oncology group ECG Electrocardiogram EE Efficacy eval uable ELISA Enzyme -linked immunosorbent assay EQ-5D-5L EuroQol 5- Dimension 5- Level EQ-5D-Y EuroQol 5- Dimension Youth FNCLCC French Federation of Comprehensive Cancer Centers GLA -SE Glucopyranosyl lipid A stable emulsion HCT Hematocrit HepB Hepatitis B HepC Hepatitis C HGB Hemoglobin HIV Human immunodeficiency virus ICF Informed consent form ICH International Conference on Harmonization 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 7 / 36 IHC Immunohistochemistry IM Intramuscular(ly) IMDZ Immune Design Corp. IPD Important protocol deviation IRC Independent review committee ITT Intent to treat IV Intravenous LAUR Locally advanced unresectable LDH Lactate dehydrogenase MCH Mean corpuscular hemoglobin MedDRA Medical Dictionary for Regulatory Activities MEOI Medical event of interest MRI Magnetic resonance imaging NED No evidence of disease NCI National cancer institute NY-ESO -1 New York esophageal squamous cell carcinoma- 1 ORR Objective response rate OS Overall survival PD Progressive disease PFS Progression- free survival PR Partial response PT Preferred term PTT Partial thromboplastin time QoL Quality of life QTc Heart rate- corrected QT interval RECIST Response evaluation criteria in solid tumors SAE Serious adverse event SC Subcutaneous(ly) SD Stable disease SOC System organ class 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 8 / 36 TEAE Treatment Emergent Adverse Event TTNT Time-to-next treatment VAS Visual a nalogue scale WBC White blood cell (count) WHO World Health Organization 05FPRF Immune Design C orp. IMDZ -04-1702 SAP Draft V1.0 for Protocol V2.0 Version Date: 2018- 05-25 Confidential 9 / 36 1 INTRODUCTION This study is a global, randomized, double -blind, placebo- controlled, phase 3 study designed to evaluate the efficacy and safety of the CMB305 vaccine regimen versus placebo in subjects with synovial sarcoma expressing NY -ESO -1. This document describes the detailed statistical methodology applied in analyzing data of the study IMDZ -04-1702. The purpose of the SAP is to ensure the credibility of the study findings by pre -specifying the statistical approaches to the analysis of study data prior to database lock. The material presented in this section is based on the trial protocol version 2.0, dated 27 April 2018.