Final phase 3 LACEWING results: gilteritinib plus azacitidine raised response rates in FLT3-mutated AML but did not prolong survival

In the final analysis of the phase 3 LACEWING study, adding gilteritinib to azacitidine did not significantly prolong overall survival in newly diagnosed FLT3-mutated acute myeloid leukaemia unfit for intensive chemotherapy: median 9.82 months versus 9.23 months for azacitidine alone (p=0.182), with gilteritinib monotherapy clearly worse at 5.24 months. The combination did more than double the overall response rate (70.2% versus 36.8%) and two-year survival was 18.8% versus 12.9%, but neither translated into a statistically significant survival gain. The trial randomised 168 patients after a 15-patient safety cohort and was followed for 6.5 years. The result is a caution that higher response rates in this population do not reliably predict longer life.