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
2020
The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML)
Zeidan A, Esteve J, Giagounidis A, Kim H, Miyazaki Y, Platzbecker U, Schuh A, Sekeres M, Westermann J, Xiao Z, Malek K, Scott J, Niolat J, Peyrard S, Ma F, Kiertsman F, Stegert M, Hertle S, Fenaux P, Santini V. The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML). Blood 2020, 136: 45-46. DOI: 10.1182/blood-2020-134718.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHematopoietic stem cell transplantationAcute myeloid leukemiaEvent-free survivalLeukemic stem cellsIntensive chemotherapyOverall survivalPrimary endpointSecondary endpointsCurrent equity holderEligible ptsTim-3Transfusion independenceCombination therapyEastern Cooperative Oncology Group performance statusCR/CRi rateEncouraging overall response rateAdvisory CommitteeDaiichi SankyoDuration of CRTransfusion-free intervalLeukemia-free survivalComplete remission rateHigh-risk MDSProgression-free survival