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ASCO 2022: Crenolanib Plus Chemotherapy in Newly Diagnosed Patients With FLT3-Mutant AML

By: Sarah Campen, PharmD
Posted: Wednesday, June 8, 2022

The type I FLT3 inhibitor crenolanib combined with standard 7+3 chemotherapy appears to yield high response rates in patients with newly diagnosed FMS-like FLT3-mutated acute myeloid leukemia (AML), according to the long-term outcomes of a phase II trial presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7007). Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, Buffalo, and colleagues reported a rate of a complete response or a complete response with incomplete hematologic recovery of 86%.

The study included 44 newly diagnosed patients with FLT3-mutant AML. After receiving 7+3 induction with cytarabine for 7 days and daunorubicin (64%) or idarubicin (36%) for 3 days, crenolanib at 100 mg three times daily was administered starting on day 9 until 72 hours prior to the next course of chemotherapy. Up to four cycles of high-dose cytarabine consolidation was allowed, and eligible patients could proceed to transplantation. Crenolanib maintenance therapy was offered for 1 year after high-dose cytarabine or transplantation.

The rates of a complete response or a complete response with incomplete hematologic recovery after one and two induction cycles were 73% and 86%, respectively. With a median follow-up of 45 months, 57% of patients are still alive, and the median overall survival for all patients has not been reached. In patients aged 60 and younger, overall survival was 69%; the median overall survival in patients older than 60 was 20 months. The cumulative incidence of relapse was 15%.

As for safety, the most common treatment-related adverse events were diarrhea (66%), nausea (57%), and febrile neutropenia (52%). Grade ≥ 3 adverse events included febrile neutropenia (50%), diarrhea (18%), nausea (6%), and rash (6%).

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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