ASCO20: 1-Year ADMIRAL Trial Update on Gilteritinib in Resistant AML
Posted: Friday, June 26, 2020
After 1 year, investigators revisited the patients with FLT3-mutated relapsed or refractory acute myeloid leukemia (AML) who participated in the phase III ADMIRAL trial to follow up on their outcomes and evaluate gilteritinib’s safety after this milestone. The agent’s safety profile beyond 1 year was stable, Alexander E. Perl, MD, of the University of Pennsylvania’s Abramson Cancer Center in Philadelphia, and colleagues reported during the ASCO20 Virtual Scientific Program (Abstract 7514).
“Median overall survival remained longer with gilteritinib (9.3 months) than with salvage chemotherapy (5.6 months; nominal P = .0026), and 18-month overall survival rates were 27% and 15%, respectively,” they reported.
The authors focused particularly on 63 gilteritinib-treated patients (of an original cohort of 247) whose overall survival was 18 months or more and whose median exposure to the drug was 17.6 months. “A high proportion of these long-term survivors achieved remission pre-[hematopoietic stem cell transplantation],” they noted. Of the 63, for instance, 45 experienced a composite complete remission. And in the 63 patients, “the median durations of complete remission or complete remission with partial hematologic recovery have not been reached.”
The researchers also documented that 35 of the 63 patients underwent hematopoietic stem cell transplantation, and 25 of these 35 received gilteritinib therapy after transplantation . Of the 28 who did not undergo transplantation, 15 received gilteritinib for 18 months or more. Based on their analysis, Dr. Perl and colleagues “suggest [that] long-term survival in patients receiving gilteritinib is related to ongoing remission, subsequent [transplantation], or post-[transplantation] gilteritinib therapy.”
The rates of all of the most common grade 3 or 4 and fatal adverse events decreased in the period after the first 12 months of gilteritinib treatment, the investigators reported. The rate of grade 3 or 4 neutropenia, for instance, decreased from 45% in the first year to 8% in the follow-up period.
Disclosure: The study authors’ disclosure information can be found at coi.asco.org.