Oncology Daily Report: 01/26/2024

A phase I/II, clinical trial study investigated the effect of azacitidine, venetoclax, and gilteritinib in 52 patients with newly diagnosed or relapsed/refractory FLT3-mutated AML and found the combined complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate was 96% in the newly diagnosed cohort and 27% in the relapsed/refractory cohort, with a recommended phase II dose of gilteritinib 80 mg once daily (1). In the newly diagnosed cohort, 65% achieved FLT3-ITD measurable residual disease <5 × 10(-5) within four cycles, and the median relapse-free survival (RFS) and overall survival (OS) have not been reached, with 18-month RFS and OS rates at 71% and 72%, respectively. The study (ClinicalTrials.gov identifier: NCT04140487) highlighted manageable myelosuppression with mitigative dosing strategies.

Reference

Short NJ, Daver N, Dinardo CD, Kadia T, Nasr LF, Macaron W, Yilmaz M, Borthakur G, Montalban-Bravo G, Garcia-Manero G, Issa GC, Chien KS, Jabbour E, Nasnas C, Huang X, Qiao W, Matthews J, Stojanik CJ, Patel KP, Abramova R, Thankachan J, Konopleva M, Kantarjian H, Ravandi F. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3-Mutated AML. J Clin Oncol. 2024 Jan 26:JCO2301911. doi: 10.1200/JCO.23.01911. Epub ahead of print. PMID: 38277619.