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Gilteritinib vs salvage chemotherapy in Asian patients with R/R FLT3-mutated AML: Results from the phase III COMMODORE trial
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The phase III multicenter, open-label, randomized COMMODORE trial (NCT03182244) assessed the safety and efficacy of gilteritinib vs SC in a predominantly Asian (85.6%) population of 234 adult patients from China, Russia, Singapore, Thailand, and Malaysia, with R/R FLT3-mutated AML.1 Interim results, at a data cutoff date of June 30, 2020, were published in Leukemia by Wang, et al.1
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The primary endpoint was met; gilteritinib improved OS compared with SC, with a median OS of 9.6 months vs 5.0 months (HR, 0.566; 95% CI, 0.392–0.818; p = 0.00211), at median follow-up of 10.3 months. Patients who received gilteritinib also had a higher median EFS compared with SC (2.8 months vs 0.6 months; HR, 0.551; 95% CI, 0.395–0.769; p = 0.00004). |
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Overall, 16.4% and 10.2% of patients treated with gilteritinib and SC achieved CR, and CRc rates were 50.0% and 20.3%, respectively. |
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When adjusted for treatment exposure, rates of Grade ≥3 AEs (58.38 E/PY vs 168.30 E/PY) and serious AEs (6.19 E/PY vs 12.40 E/PY) were lower with gilteritinib compared with SC. The most common AEs observed in patients treated with gilteritinib were anemia (77.9%), thrombocytopenia (45.1%), pyrexia (44.2%), and increased blood LDH (44.2%). |
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Results from the COMMODORE trial demonstrate that gilteritinib was well tolerated and improved survival outcomes vs SC in patients with R/R FLT3-mutated AML. Furthermore, these findings confirm that the efficacy and safety findings from the phase III ADMIRAL trial also apply to a predominantly Asian patient population. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CI, confidence interval; CR, complete remission; CRc, composite CR; E/PY, event/patient-year; EFS, event-free survival; HR, hazard ratio; LDH, lactate dehydrogenase; OS, overall survival; R/R, relapsed/refractory; SC, salvage chemotherapy.
- Wang J, Jiang B, Liu L, et al. Phase 3 study of gilteritinib versus salvage chemotherapy in predominantly Asian patients with relapsed/refractory FLT3-mutated acute myeloid leukemia. Leukemia. 2024. Online ahead of print. DOI: 10.1038/s41375-024-02382-9
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