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Adding the CD33-targeted antibody-drug conjugate gemtuzumab ozogamicin to two courses of chemotherapy reduced relapses in childhood acute myeloid leukaemia, most clearly in the high-risk group, and it was later restored to the paediatric label.
Phase 3 trial of 1,022 children, adolescents and young adults with newly diagnosed AML randomised to standard chemotherapy with or without gemtuzumab ozogamicin in induction and intensification.
Event-free survival at three years was 53.1 versus 46.9 percent (hazard ratio 0.83) with relapse risk reduced from 41 to 33 percent; overall survival was not significantly different (69.4 versus 65.4 percent), and benefit was greatest in high-risk patients and those with high CD33 expression.
Gemtuzumab ozogamicin is part of standard induction for CD33-positive childhood AML in Children's Oncology Group protocols.
Shares COG AAML0531, Gemtuzumab ozogamicin.
Shares COG AAML0531, Gemtuzumab ozogamicin, Acute myeloid leukaemia in children.
Shares Acute myeloid leukaemia in children, Journal of Clinical Oncology.
Shares Gemtuzumab ozogamicin, Acute myeloid leukaemia in children.
Shares Gemtuzumab ozogamicin, Acute myeloid leukaemia in children.