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Gilteritinib Reevaluated for FLT3-Mutated AML: Follow-up From ADMIRAL Trial

By: Celeste L. Dixon
Posted: Friday, October 29, 2021

Patients with FLT3-mutated, relapsed, or refractory acute myeloid leukemia (AML) treated with the tyrosine kinase inhibitor gilteritinib may be more likely than those treated with salvage chemotherapy to maintain remission, according to a follow-up analysis of the phase III ADMIRAL trial. Mark James Levis, MD, PhD, of the Sidney Kimmel Comprehensive Cancer at Johns Hopkins University in Baltimore, and colleagues shared their results during Blood 2021, the virtual combined annual meeting of the Haematology Society of Australia and New Zealand, Australian and New Zealand Society of Blood Transfusion, and Thrombosis and Haemostasis Society of Australia and New Zealand (Abstract 09.18). The initial study results showed a benefit with gilteritinib, but the team wanted to assess longer-term survival, hematopoietic stem cell transplantation (HSCT) outcomes, and safety beyond 1 year.

After analysis, the investigators concluded that a high proportion of patients who had received gilteritinib and were living without relapse had received an HSCT followed by gilteritinib maintenance. The team noted that rates of pre-HSCT remission and post-HSCT survival were similar across arms and that “successful post-HSCT gilteritinib maintenance therapy may relate to the low post-HSCT relapse rate in gilteritinib-treated patients.” Additionally, the 2-year safety profile of gilteritinib appeared to be stable.

As of September 2020, 17% (63 of 371) of the intent-to-treat patients were alive: 49 and 14 on the gilteritinib and standard-care arms, respectively. A total of 26 patients who had received gilteritinib were alive, without relapse, after a median of 37.1 months. Of these 26 patients, 18 had received HSCT, 16 had received post-HSCT gilteritinib therapy, and 19 had continued gilteritinib beyond 1 year and remained in complete remission.

Also, 22% (83 of 371) of the intent-to-treat patients received an on-study HSCT: 64 and 19 on the gilteritinib and standard-care arms, respectively. Of those 64 patients who had received gilteritinib, 40 had received post-HSCT gilteritinib maintenance after pre-HSCT composite complete response.

Disclosure: The study authors reported no conflicts of interest.



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