{"entity":{"id":"paper-amer-zeidan-j-clin-oncol-2021","kind":"paper","name":"Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia","aka":[],"tldr":"Paper by Amer M. Zeidan indexed on Europe PMC as PubMed record 33119479, in Journal of Clinical Oncology (2021), one of the most cited records naming an author with this name at Yale Cancer Center / Smilow Cancer Hospital.","summary":"Purpose: Ivosidenib is an oral inhibitor of the mutant isocitrate dehydrogenase 1 (IDH1) enzyme, approved for treatment of IDH1 -mutant (m IDH1) acute myeloid leukemia (AML). Preclinical work suggested that addition of azacitidine to ivosidenib enhances mIDH1 inhibition-related differentiation and apoptosis.\n\nPatients and methods: This was an open-label, multicenter, phase Ib trial comprising dose-finding and expansion stages to evaluate safety and efficacy of combining oral ivosidenib 500 mg once daily continuously with subcutaneous azacitidine 75 mg/m 2 on days 1-7 in 28-day cycles in patients with newly diagnosed m IDH1 AML ineligible for intensive induction chemotherapy (ClinicalTrials.gov identifier: NCT02677922).\n\nResults: Twenty-three patients received ivosidenib plus azacitidine (median age, 76 years; range, 61-88 years). Treatment-related grade ≥ 3 adverse events occurring in > 10% of patients were neutropenia (22%), anemia (13%), thrombocytopenia (13%), and electrocardiogram QT prolongation (13%). Adverse events of special interest included all-grade IDH differentiation syndrome (17%), all-grade electrocardiogram QT prolongation (26%), and grade ≥ 3 leukocytosis (9%). Median treatment duration was 15.1 months (range, 0.3-32.2 months); 10 patients remained on treatment at February 19, 2019. The overall response rate was 78.3% (18/23 patients; 95% CI, 56.3% to 92.5%), and the complete remission rate was 60.9% (14/23 patients; 95% CI, 38.5% to 80.3%). With median follow-up of 16 months, median duration of response in responders had not been reached. The 12-month survival estimate was 82.0% (95% CI, 58.8% to 92.8%). m IDH1 clearance in bone marrow mononuclear cells by BEAMing (beads, emulsion, amplification, magnetics) digital polymerase chain reaction was seen in 10/14 patients (71.4%) achieving complete remission.\n\nConclusion: Ivosidenib plus azacitidine was well tolerated, with an expected safety profile consistent with monotherapy with each agent. Responses were deep and durable, with most complete responders achieving m IDH1 mutation clearance.\n\nIndexed on Europe PMC as PubMed record 33119479 (DOI 10.1200/jco.20.01632). Its author list gives \"Zeidan AM\" with the affiliation \"Yale Cancer Center, New Haven, CT\", which names Yale Cancer Center / Smilow Cancer Hospital; that is how the record was matched to Amer M. Zeidan, and no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"J Clin Oncol 2021","url":"https://doi.org/10.1200/jco.20.01632"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/33119479/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/33119479"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["amer-zeidan"],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2021,"doi":"10.1200/jco.20.01632","pmid":"33119479","authors":"DiNardo CD, Stein AS, Stein EM, et al.","paperType":"observational","findings":[],"whatItMeans":"One of the most cited papers Europe PMC returns for Amer M. Zeidan at Yale Cancer Center / Smilow Cancer Hospital, so it is a natural starting point for reading their work. The record was linked automatically from the author list and affiliation; read the abstract above and the paper itself before relying on any figure.","caveats":["Matched to the person by surname, initials and an affiliation string naming the institution on the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.","Two authors sharing a surname, initials and institution cannot be told apart by this method; the person's profile links are the place to confirm authorship."]},"route":"/key-papers/paper-amer-zeidan-j-clin-oncol-2021/","neighbours":{"person":[{"id":"amer-zeidan","kind":"person","name":"Amer M. Zeidan","route":"/people/amer-zeidan/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}