1982;5:649 -655. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 262 12.5. Appendix 5. Revised Recommendations of The International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 263 Response Criteria in AML Response Criterion Time of Assessment Neutrophils (µ/L) Platelets (µ/L) Bone Marrow Blasts (%) Other Early treatment assessment 7-10 days after therapy NA NA < 5 Morphologic leukemia -free state Varies by protocol NA NA < 5 Flow cytometry EMD Morphologic CR Varies by protocol >1,000 > 100,000 < 5 Transfusion EMD Cytogenetic CR Varies by protocol >1,000 > 100,000 < 5 Cytogenics - normal, EMD Molecular CR Varies by protocol >1,000 > 100,000 < 5 Molecular - negative, EMD Partial remission (PR) Varies by protocol > 1,000 > 100,000 > 50% decrease vs baseline or decrease to 5-25% Blasts < 5% if Auer rod positive (FAB M2 & M3 subtypes only) Abbreviations: AML, acute myelogenous leukemia; EMD, extramedullary disease; CR, complete remission. From: Cheson BD, Bennett, JM, Kopecky, KJ, et al. Revised recommendations of the Internation al Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol.