Key clinical point: The addition of gemtuzumab ozogamycin (GO) to standard chemotherapy (SC) did not improve survival in younger patients with de novo acute myeloid leukemia (AML) and intermediate-risk (IR) cytogenetics but was associated with significantly higher toxicities.
Major finding: During a median follow-up of 35 months, event-free survival (hazard ratio [HR], 1.35; P = .116) and overall survival (HR, 1.35; P = .146) were not different in patients receiving GO+SC vs. SC alone. Duration of neutropenia ( P = .03) and thrombopenia ( P less than .001) and grade 3/4 liver toxicities ( P = .03) were significantly higher in patients receiving GO vs. SC alone.
Study details: Phase 3 AML 2006-IR trial included 238 younger patients (age, 18-60 years) with de novo AML and IR cytogenetics randomly assigned to receive cytarabine and daunorubicin with or without GO. GO arm was prematurely closed after 254 inclusions because of toxicity and early deaths.
Disclosures: This study was supported by the French government PHRC 2006 and PFIZER group. Some investigators reported being on advisory boards, receiving research and travel funding, honoraria, and personal fees from various pharmaceutical companies, including Pfizer.
Source: Bouvier A et al. Eur J Haematol. 2021 Mar 25. doi: 10.1111/ejh.13626 .