Management of important adverse events associated with inotuzumab ozogamicin: expert panel review

Partow Kebriaei, Corey Cutler, Marcos de Lima, Sergio Giralt, Stephanie J Lee, David Marks, Akil Merchant, Wendy Stock, Koen van Besien, Matthias Stelljes, Partow Kebriaei, Corey Cutler, Marcos de Lima, Sergio Giralt, Stephanie J Lee, David Marks, Akil Merchant, Wendy Stock, Koen van Besien, Matthias Stelljes

Abstract

Inotuzumab ozogamicin (InO), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, has demonstrated efficacy in the phase 3 INO-VATE study of adults with relapsed or refractory acute lymphoblastic leukemia (ALL). Findings from the study showed clinically important adverse events (AEs) associated with InO, with veno-occlusive disease (VOD) reported as a major non-hematologic AE. Other important or serious AEs include neutropenia, febrile neutropenia, thrombocytopenia, infusion-related reactions, tumor lysis syndrome, and prolonged QT syndrome. This report summarizes the recommendations of an expert panel of hematologists and transplant physicians for evaluation and management of the important AEs associated with InO, with a focus on diagnosis, prevention, monitoring, and management of VOD. The possible interventions considered included prophylaxis medications, patient monitoring and assessment, and InO dose adjustment or discontinuation.

Trial registration: ClinicalTrials.gov NCT01564784.

Conflict of interest statement

Pfizer Inc sponsored the study for which data on file are reported (INO-VATE Clinicaltrials.gov number: NCT01564784). M.S. has served on consultancy and advisory boards for Pfizer Inc, Amgen, and Jazz Pharmaceuticals and has received research support from Pfizer. P.K., C.C., M.D.L., S.G., S.L., D.M., A.M., W.S., and K.V.B. have served on advisory boards for Pfizer Inc. Editorial support was provided by Anny Wu, PharmD, of Complete Healthcare Communications, LLC, and funded by Pfizer Inc.

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Source: PubMed

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