2023
STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2
Zeidan A, Giagounidis A, Sekeres M, Xiao Z, Sanz G, Van Hoef M, Ma F, Hertle S, Santini V. STIMULUS-MDS2 design and rationale: a phase III trial with the anti-TIM-3 sabatolimab (MBG453) + azacitidine in higher risk MDS and CMML-2. Future Oncology 2023, 19: 631-642. PMID: 37083373, DOI: 10.2217/fon-2022-1237.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsHigh-risk myelodysplastic syndromeChronic myelomonocytic leukemiaMyelodysplastic syndromeCMML-2Tim-3Hematopoietic stem cell transplantationT-cell immunoglobulin domainMucin domain 3Risk myelodysplastic syndromesPhase III trialsStem cell transplantationLeukemic stem cellsFavorable tolerabilityIII trialsNovel immunotherapiesPoor outcomeCell transplantationLeukemic blastsClinical trialsNovel therapiesMyelomonocytic leukemiaDurable benefitImmune systemMyeloid malignanciesMeaningful improvements
2021
Health-Related Quality of Life (HRQoL) during Treatment with Enasidenib (ENA) Plus Azacitidine (AZA) in Patients with Newly Diagnosed Mutant IDH2 (m IDH2) Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy (IC)
DiNardo C, Dohner H, Zeidan A, Schuh A, Vyas P, Stein E, Wei A, de Botton S, Chen C, Lord-Bessen J, Martin-Regueira P, Lersch F, Gong J, Guo S, Shi L, Montesinos P. Health-Related Quality of Life (HRQoL) during Treatment with Enasidenib (ENA) Plus Azacitidine (AZA) in Patients with Newly Diagnosed Mutant IDH2 (m IDH2) Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy (IC). Blood 2021, 138: 1244. DOI: 10.1182/blood-2021-147601.Peer-Reviewed Original ResearchClinical Trials CommitteeAcute myeloid leukemiaEQ-5D VASQLQ-C30 domainsCurrent equity holderBristol-Myers SquibbGHS/QoLGlobal health statusOverall response rateTrials CommitteeQLQ-C30 scoresEQ-5DIntensive chemotherapyPhysical functioningRole functioningDaiichi SankyoSpeakers bureauEvaluable ptsBristol-Myers Squibb CompanyHRQoL scoresDyspnea domainEQ-5D visual analog scale scoresJazz PharmaceuticalsMeaningful improvementsVisual analog scale score