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Association details:
| Biomarker: | FLT3-ITD mutation + FLT3-TKD mutation |
|---|---|
| Cancer: | Acute Myelogenous Leukemia |
| Drug: | Xospata (gilteritinib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
GILTERITINIB VERSUS SALVAGE CHEMOTHERAPY FOR RELAPSED/REFRACTORY FLT3-MUTATED ACUTE MYELOID LEUKEMIA: A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL TRIAL IN ASIA
Published date:
05/12/2022
Excerpt:
Baseline FLT3 mutations in the gilteritinib vs SC groups were: FLT3-ITD (91.4% vs 83.1%), FLT3-TKD (6.0% vs 11.9%), and both FLT3-ITD and FLT3-TKD (2.6% vs 5.1%). Median OS follow-up duration was 11.1 mo for gilteritinib and 6.9 mo for SC. Median OS was longer with gilteritinib (9.0 mo) vs SC (4.7 mo; HR 0.549 [95% CI: 0.379, 0.795]; P=0.00126); 1-year survival rate was 33.3% and 23.2%, respectively. OS benefit was seen with gilteritinib vs SC across most subgroups (Figure). Pts on gilteritinib had longer EFS than pts on SC (median EFS 2.8 vs 0.6 mo; HR 0.551 [95% CI: 0.395, 0.769]; P=0.00004). More pts had CR on gilteritinib (16.4%) vs SC (10.2%; P=0.17690); CRc rates were 50.0% and 20.3% (P<0.00001). Gilteritinib significantly prolonged OS and EFS vs SC in pts with R/R FLT3mut+ AML in Asia.
Trial ID:
