{"entity":{"id":"quantum-first","kind":"trial","name":"QuANTUM-First","aka":[],"tldr":"Roughly doubled median survival in the most aggressive FLT3 subtype by adding a selective FLT3 blocker to chemotherapy, including in patients over 60.","summary":"Median OS 31.9 vs 15.1 months (HR 0.776, 95% CI 0.615-0.979, p=0.032) at 39.2 months median follow-up; CR rates similar but relapse-free survival and MRD-negative remissions improved; benefit maintained when censored at transplant. Lancet 2023. Basis for the July 2023 US approval. Its inclusion of patients up to 75 extended the RATIFY concept to older adults.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02668653","url":"https://clinicaltrials.gov/study/NCT02668653"},{"label":"Lancet 2023","url":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00464-6/fulltext"}],"tags":[],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":["quizartinib","cytarabine-7-3"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["richard-stone"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02668653","phase":"3","setting":"Newly diagnosed FLT3-ITD AML, age 18-75: quizartinib vs placebo with 7+3, consolidation, and up to 3 years of maintenance","sponsor":"Daiichi Sankyo","result":"OS 31.9 vs 15.1 months; HR 0.776.","started":"2016-09-01","startedType":"actual","yearReported":2022,"enrolled":539,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Quizartinib + 7+3","n":268,"value":31.9},{"name":"Placebo + 7+3","n":271,"value":15.1}],"hr":0.776,"ci":[0.615,0.979],"p":"0.032","source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00464-6/fulltext"}],"replication":"Consistent with RATIFY (midostaurin); the FLT3-inhibitor-plus-7+3 effect has now been shown with two different molecules."},"route":"/trials/quantum-first/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-flt3","kind":"cancer","name":"FLT3-mutated acute myeloid leukaemia","route":"/cancers/aml-flt3/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"flt3","kind":"target","name":"FLT3","route":"/targets/flt3/"}],"drug":[{"id":"cytarabine-7-3","kind":"drug","name":"Cytarabine + anthracycline ('7+3')","route":"/drugs/cytarabine-7-3/"},{"id":"quizartinib","kind":"drug","name":"Quizartinib","route":"/drugs/quizartinib/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"person":[{"id":"richard-stone","kind":"person","name":"Richard M. Stone","route":"/people/richard-stone/"}],"pairing":[{"id":"flt3i-plus-7-3","kind":"pairing","name":"FLT3 inhibitor + intensive chemotherapy","route":"/pairings/flt3i-plus-7-3/"}],"paper":[{"id":"paper-quantum-first-quizartinib-lancet-2023","kind":"paper","name":"QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML","route":"/key-papers/paper-quantum-first-quizartinib-lancet-2023/"}]}}