{"entity":{"id":"ino-vate","kind":"trial","name":"INO-VATE ALL","aka":[],"tldr":"An antibody-drug conjugate put four in five relapsed ALL patients into remission versus fewer than one in three with chemotherapy.","summary":"INO-VATE ALL, trial NCT01564784 sponsored by Pfizer and published in the New England Journal of Medicine in 2016, showed that the CD22 antibody-drug conjugate inotuzumab ozogamicin put four in five adults with relapsed or refractory B-cell acute lymphoblastic leukaemia into remission versus fewer than one in three with intensive chemotherapy. It randomised 326 patients, met its primary remission endpoint with far higher MRD negativity and four times as many patients proceeding to transplant, while overall survival was not significantly different at the prespecified boundary, and hepatic veno-occlusive disease occurred in about a tenth. Whether lower frontline doses avoid the liver toxicity is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01564784","url":"https://clinicaltrials.gov/study/NCT01564784"}],"tags":[],"related":[],"cancers":["all-leukemia"],"sections":[],"technologies":["adc"],"targets":["cd22"],"drugs":["inotuzumab-ozogamicin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["elias-jabbour","hagop-kantarjian"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01564784","phase":"3","setting":"Relapsed or refractory CD22+ B-ALL, adults: inotuzumab ozogamicin vs standard intensive chemotherapy","sponsor":"Pfizer","result":"CR/CRi 80.7% vs 29.4%; OS 7.7 vs 6.7 months.","started":"2012-08-02","startedType":"actual","yearReported":2016,"enrolled":326,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission / CRi","primary":true,"unit":"%","arms":[{"name":"Inotuzumab","n":109,"value":80.7},{"name":"Chemotherapy","n":109,"value":29.4}],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1509277"},{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Inotuzumab","n":164,"value":7.7},{"name":"Chemotherapy","n":162,"value":6.7}],"hr":0.77,"ci":[0.58,1.03],"p":"0.04 (did not meet boundary)","source":"https://doi.org/10.1056/NEJMoa1509277"}],"replication":"Paediatric ITCC-059 and COG AALL1621 reproduced ~60-80% remission rates; frontline Mini-hyper-CVD + InO series show high MRD negativity in older adults."},"route":"/trials/ino-vate/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cd22","kind":"target","name":"CD22","route":"/targets/cd22/"}],"drug":[{"id":"inotuzumab-ozogamicin","kind":"drug","name":"Inotuzumab ozogamicin","route":"/drugs/inotuzumab-ozogamicin/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"person":[{"id":"elias-jabbour","kind":"person","name":"Elias Jabbour","route":"/people/elias-jabbour/"},{"id":"hagop-kantarjian","kind":"person","name":"Hagop M. Kantarjian","route":"/people/hagop-kantarjian/"}]}}