AI Article Synopsis

  • Gilteritinib, a FLT3 inhibitor, was recently approved in Japan as an effective treatment for FLT3-mutated relapsed/refractory acute myeloid leukemia (AML), showing better overall survival than salvage chemotherapy in the ADMIRAL trial.
  • In the Japanese subgroup analysis, patients on gilteritinib had a median overall survival of 14.3 months compared to 9.6 months for those on salvage chemotherapy, with higher complete remission rates.
  • Gilteritinib also resulted in fewer adverse events, although some patients experienced significant issues like febrile neutropenia and anemia.

Article Abstract

Background: Until recently, no effective targeted therapies for FLT3-mutated (FLT3 relapsed/refractory (R/R) acute myeloid leukemia (AML) were available in Japan. The FLT3 inhibitor, gilteritinib, was approved in Japan for patients with FLT3 R/R AML based on the phase 3 ADMIRAL trial, which demonstrated the superiority of gilteritinib over salvage chemotherapy (SC) with respect to overall survival (OS; median OS, 9.3 vs 5.6 months, respectively; hazard ratio, 0.64 [95% confidence interval 0.49, 0.83]; P < 0.001).

Methods: We evaluated the Japanese subgroup (n = 48) of the ADMIRAL trial, which included 33 patients randomized to 120-mg/day gilteritinib and 15 randomized to SC.

Results: Median OS was 14.3 months in the gilteritinib arm and 9.6 months in the SC arm. The complete remission/complete remission with partial hematologic recovery rate was higher in the gilteritinib arm (48.5%) than in the SC arm (13.3%). After adjustment for drug exposure, fewer adverse events (AEs) occurred in the gilteritinib arm than in the SC arm. Common grade ≥ 3 AEs related to gilteritinib were febrile neutropenia (36%), decreased platelet count (27%), and anemia (24%).

Conclusion: Findings in Japanese patients are consistent with those of the overall ADMIRAL study population.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522999PMC
http://dx.doi.org/10.1007/s10147-021-02006-7DOI Listing

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