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Post hoc analysis of the ADMIRAL and COMMODORE trials: Timing of response with gilteritinib monotherapy in R/R FLT3m AML
Gilteritinib is approved for the treatment of patients with R/R FLT3m AML. While salvage chemotherapy usually induces a response within two cycles, gilteritinib monotherapy may require 1–3 months for blast clearance and several months for marrow response.1 During the 66th ASH Annual Meeting and Exposition, Wang presented findings from a post hoc analysis of the two phase III trials – ADMIRAL and COMMODORE – investigating the timing of response to gilteritinib in patients with R/R FLT3m AML. A total of 166 patients treated with gilteritinib and who achieved CRc prior to on-study HSCT were included; 36.1% of these were early responders (achieving CRc by end of Cycle 2) and 63.9% were late responders (achieving CRc after initiation of Cycle 3).
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| Key learnings |
| Of patients who achieved CRc, 89.2% attained remission within six cycles of gilteritinib monotherapy. Median duration of CRc was 2.7 months in early responders and 3.5 months in late responders. |
| Females and those with a NPM1 co-mutation had a higher likelihood of being an early responder. 18.9% of late and 23.3% of early responders received on-study HSCT after CRc; of these, 60.0% vs 21.4%, respectively, achieved CR with full count recovery before HSCT. |
| 12-month OS was 39.1% for late and 27.9% for early responders; drug-related Grade ≥3 TEAEs were 7.8 E/PY and 11.4 E/PY, respectively, with 34.0% and 41.7% discontinuing treatment due to relapse and 22.6% and 25.0% due to progression. |
| The results support continued gilteritinib monotherapy in patients with R/R FLT3m AML who can tolerate it, given the potential for late sustained remission. Therefore, unlike salvage therapy, treatment continuation decisions for gilteritinib should account for late responses as well. |
AML, acute myeloid leukemia; CR, complete remission; CRc, composite complete remission; E, event; FLT3m, FLT3-mutated; HSCT, hematopoietic stem cell transplantation; PY, patient-year; R/R, relapsed/refractory; TEAE, treatment-emergent adverse event.
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