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Aspacytarabine is Safe, Well-Tolerated for Patients With Newly Diagnosed AML
Data from a phase 2b study on aspacytarabine, a prodrug of cytarabine, as a single agent for induction and consolidation therapy for patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for standard induction chemotherapy, were presented at the 2021 American Society of Hematology (ASH) Annual Meeting.
The primary endpoint of the study was complete remission (CR) with complete hematological recovery.
A total of 65 newly diagnosed AML patients with a median age of 75 years (range 54-88 years) unfit for standard chemotherapy were treated with 6-day courses of 4.5 g/m2/d aspacytarabine. Patients completed 1-4 courses of therapy. Of these patients, 39 had de novo AML and 26 had secondary AML.
Aspacytarabine was well-tolerated in repeated-course administration and no severe gastrointestinal or neurological events occurred. Grade ≥3 adverse events (AEs) included hematological events and infections.
“Of the 65 intention-to-treat AML patients, 24 (37%) achieved a CR following 1 (17 patients) or 2 (7 patients) courses. The median time to complete neutrophil and platelet recovery were 27 days (range 11-39 days) and 26 days (range 18-40), respectively,” wrote Dr Jessica Altman, Northwestern University, Chicago and colleagues.
The CR rates in de novo patients were 44%, and in secondary AML patients were 27%. Of the patients with prior HMA therapy, CR was met by 27%.
“Aspacytarabine appears to be an effective regimen for AML with a considerable reduction of the attendant toxicities that typically are associated with standard intensive cytotoxic therapies. The results of the phase 2b study are consistent with the previously completed phase 1/2a study, which demonstrated safety and a 36% CR rate in a similar population, suggest that aspacytarabine, given as monotherapy, is generally safe and effective as a first-line therapy for AML patients who are unfit for intensive chemotherapy,” concluded Dr Altman and colleagues.
Jessica A, Koprivnikar J, McCloskey JK, et al. Aspacytarabine (BST-236) As Monotherapy Is Safe, Well-Tolerated and Effective for the Treatment of Adults with Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Therapy. Results of a Phase 2 Study. Presented at: the 2021 ASH Annual Meeting; Dec. 11-14; 2021; Abstract 1273.
