{"entity":{"id":"phallcon","kind":"trial","name":"PhALLCON","aka":[],"tldr":"Head to head, the third-generation TKI ponatinib doubled the rate of deep, undetectable remission over imatinib in newly diagnosed Ph-positive ALL.","summary":"PhALLCON, trial NCT03589326 sponsored by Takeda and published in JAMA in 2024, was the first randomised comparison of tyrosine kinase inhibitors in newly diagnosed Philadelphia-positive acute lymphoblastic leukaemia, and it showed that ponatinib doubles the rate of deep, MRD-negative remission over imatinib when each is given with reduced-intensity chemotherapy. It randomised 245 adults and met its primary endpoint of MRD-negative complete remission at the end of induction, with fewer treatment failures and comparable arterial occlusive events at the reduced dosing, leading to accelerated approval in March 2024. OnCo links it to acute lymphoblastic leukaemia, BCR::ABL1 as a target, ponatinib, imatinib, the Ph-positive ALL term and the pairing of a BCR::ABL1 inhibitor with blinatumomab. Whether chemotherapy can be dropped entirely with ponatinib plus blinatumomab is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03589326","url":"https://clinicaltrials.gov/study/NCT03589326"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["bcr-abl"],"drugs":["ponatinib","imatinib"],"companies":["takeda"],"institutions":[],"pathways":[],"terms":["ph-positive-all","mrd-negative-cr"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03589326","phase":"3","setting":"Newly diagnosed Ph-positive ALL, adults: ponatinib vs imatinib, each with reduced-intensity chemotherapy","sponsor":"Takeda","result":"MRD-negative CR 34.4% vs 16.7%.","started":"2018-10-04","startedType":"actual","yearReported":2024,"enrolled":245,"enrolledBasis":"registry","outcomes":[{"endpoint":"MRD-negative complete remission at end of induction","primary":true,"unit":"%","arms":[{"name":"Ponatinib + chemotherapy","n":164,"value":34.4},{"name":"Imatinib + chemotherapy","n":81,"value":16.7}],"p":"0.002","source":"https://jamanetwork.com/journals/jama/fullarticle/2819187"}],"replication":"Single-arm hyper-CVAD + ponatinib series (MD Anderson) report 5-year OS ~75%; GIMEMA and GRAAPH studies with dasatinib/nilotinib show lower molecular response rates, consistent with a class-potency effect."},"route":"/trials/phallcon/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-ph-positive","kind":"cancer","name":"Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)","route":"/cancers/all-paediatric-ph-positive/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"},{"id":"ponatinib","kind":"drug","name":"Ponatinib","route":"/drugs/ponatinib/"}],"company":[{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}],"term":[{"id":"mrd-negative-cr","kind":"term","name":"MRD-negative complete remission","route":"/terms/mrd-negative-cr/"},{"id":"ph-positive-all","kind":"term","name":"Ph-positive ALL","route":"/terms/ph-positive-all/"}],"pairing":[{"id":"tki-plus-blinatumomab-ph-all","kind":"pairing","name":"BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL)","route":"/pairings/tki-plus-blinatumomab-ph-all/"}]}}