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Gilteritinib Versus Chemotherapy in Asian Patients With Resistant AML: Phase III Trial

By: Vanessa A. Carter, BS
Posted: Friday, January 14, 2022

Jianxiang Wang, MD, of State Key Laboratory of Experimental Hematology, Tianjin, China, and colleagues conducted the phase III COMMODORE trial assessing the safety and tolerability of the oral FLT3 inhibitor gilteritinib versus salvage chemotherapy in relapsed or refractory acute myeloid leukemia (AML). During the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 695), the study authors reported significantly prolonged event-free and overall survival with gilteritinib compared with chemotherapy.

This open-label, multicenter trial enrolled 234 patients across Asia with relapsed or refractory, FLT3-mutated AML who had an Eastern Cooperative Oncology Group performance score of at most 2. Participants were randomly assigned to receive gilteritinib (n = 116) or salvage chemotherapy (n = 118) over continuous 28-day cycles.

The median follow-up for overall survival was 11.1 months for patients given gilteritinib and 6.9 months for those given chemotherapy. Median overall survival was significantly longer with gilteritinib versus chemotherapy (P = .00126), and the 1-year survival rates were 33.3% and 23.2%, respectively; median event-free survival was also significantly improved with gilteritinib (P = .00004). Notably, more patients given gilteritinib (16.4%) achieved a complete response than those given salvage chemotherapy (10.2%).

Adverse events of grade 3 or greater affected most patients on both treatments (97.3% vs. 94.2%), although serious events were more common with gilteritinib (73.5%) than with chemotherapy (61.5%). When the study authors adjusted for treatment exposure, however, these rates appeared to be lower with gilteritinib. Additionally, anemia and thrombocytopenia were among the most common adverse events for both treatment groups. Of note, adverse event–related deaths were reported in 19.5% and 14.4% of patients receiving gilteritinib and chemotherapy, respectively.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.


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