TOKYO, Mar 25 (Pulse News Wire) – Delta-fly Pharma,inc. (4598.T) reported positive results from its phase 1/2 clinical trial combining DFP-101 with venetoclax for relapsed/refractory acute myeloid leukemia (AML).
The trial, conducted across four sites in the United States, showed no dose-limiting toxicities in six patients during the initial phase. In the expanded phase, 17 patients received the treatment regimen, which included DFP-101 at 4 mg/m²/day continuous infusion for 14 days plus venetoclax at 400 mg/day for 10 days. The Data Monitoring Committee (DMC) concluded that the modified dosing regimen was safe and well-tolerated, recommending its continued use in future trials.
Additionally, the overall response rate was 33.3% in the expansion cohort, with three partial responses and three minor responses observed. Four patients progressed to stem cell transplantation based on these outcomes. Despite the initial requirement of nine out of 17 patients showing efficacy due to prior exposure to venetoclax, the DMC deemed the achieved response rates sufficient to warrant further investigation.
As a result, the company plans to hold discussions with the FDA to prepare for transitioning to a phase 3 clinical trial.
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