Safety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia.

TitleSafety of gemtuzumab ozogamicin as monotherapy or combination therapy in an expanded-access protocol for patients with relapsed or refractory acute myeloid leukemia.
Publication TypeJournal Article
Year of Publication2020
AuthorsWang ES, Aplenc R, Chirnomas D, Dugan M, Fazal S, Iyer S, Lin TL, Nand S, Pierce KJ, Shami PJ, Vermette JJ, Abboud CN
JournalLeuk Lymphoma
Pagination1-9
Date Published2020 May 20
ISSN1029-2403
Abstract

Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved. Patients were aged ≥3 months with relapsed/refractory (R/R) acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or acute promyelocytic leukemia (APL), and had exhausted other treatment options. Three hundred and thirty one patients received GO as monotherapy for R/R AML ( 139), combination therapy for R/R AML ( 183), or treatment for R/R APL ( 9). Corresponding treatment discontinuations occurred in 68, 39, and 33% of patients. All-causality grade 5 AEs occurred in 52, 22, and 22% of patients in the monotherapy, combination, and APL groups, respectively. Corresponding grades 3 and 4 treatment-related AEs were reported in 60, 55 and 78% of patients. Hepatotoxicity occurred in five patients: veno-occlusive disease ( 4) and drug-induced liver injury ( 1). GO was generally well tolerated in patients with R/R AML or APL. Most frequent treatment-related grade ≥3 AEs were hematologic AEs. NCT02312037.

DOI10.1080/10428194.2020.1742897
Alternate JournalLeuk. Lymphoma
PubMed ID32432489