2022
Primary Results of Stimulus-MDS1: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of TIM-3 Inhibition with Sabatolimab Added to Hypomethylating Agents (HMAs) in Adult Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
Zeidan A, Ando K, Rauzy O, Turgut M, Wang M, Cairoli R, Hou H, Kwong Y, Sangerman M, Meers S, Pullarkat V, Santini V, Malek K, Kiertsman F, Lyu J, Ramos P, Fenaux P, Miyazaki Y, Platzbecker U. Primary Results of Stimulus-MDS1: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of TIM-3 Inhibition with Sabatolimab Added to Hypomethylating Agents (HMAs) in Adult Patients with Higher-Risk Myelodysplastic Syndromes (MDS). Blood 2022, 140: 2063-2065. DOI: 10.1182/blood-2022-158612.Peer-Reviewed Original ResearchRandomized Phase II Study to Assess the Role of Nivolumab As Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients after Chemotherapy (NCI9706 protocol; REMAIN Trial)
Liu H, Sharon E, Karrison T, Zha Y, Fulton N, Streicher H, Sweet K, Yaghmour G, Liu J, Jonas B, Schimmer A, Grant S, Zeidan A, Hildebrandt G, Hourigan C, Lowrey C, Mattison R, Palmisiano N, Salhotra A, Tzachanis D, Baer M, Lin T, Patel P, Chen H, Stadler W, Odenike O, Larson R, Gajewski T, Stock W. Randomized Phase II Study to Assess the Role of Nivolumab As Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients after Chemotherapy (NCI9706 protocol; REMAIN Trial). Blood 2022, 140: 1716-1719. DOI: 10.1182/blood-2022-157326.Peer-Reviewed Original Research
2021
MDS-364: STIMULUS MDS-US Trial in Progress: Evaluating Sabatolimab in Combination with Hypomethylating Agents (HMAs) in Patients with Intermediate-, High-, or Very High–Risk Myelodysplastic Syndromes (MDS)
Zeidan A, DeZern A, Borate U, Kobata K, Sadek I, Sabo J, Purkayastha D, Ramos P, Sun H, Lyons R, Garcia-Manero G. MDS-364: STIMULUS MDS-US Trial in Progress: Evaluating Sabatolimab in Combination with Hypomethylating Agents (HMAs) in Patients with Intermediate-, High-, or Very High–Risk Myelodysplastic Syndromes (MDS). Clinical Lymphoma Myeloma & Leukemia 2021, 21: s348-s349. DOI: 10.1016/s2152-2650(21)01808-5.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeMyelodysplastic syndromeHypomethylating agentAdverse eventsInvestigator's choiceCR/PRHematopoietic stem cell transplantDuration of CROral hypomethylating agentLeukemia-free survivalPhase Ib studyPhase II studySerious adverse eventsComplete remission ratePercentage of patientsProgression-free survivalMonths of treatmentStem cell transplantFavorable safety profileExperience poor outcomesNormal hematopoietic stem cellsMultiple phase IMyeloid leukemic cellsEligible patientsOral decitabine