Delta-Fly Pharma, Inc. has announced encouraging initial results from its Phase I/II study evaluating the combination of DFP-10917 and venetoclax in patients with acute myeloid leukemia (AML) who have previously been treated with venetoclax. The study is designed to assess the safety and efficacy of this novel combination as a potential alternative to standard chemotherapy regimens.
Early Phase I/II Results
According to the company, the first three patients enrolled in the Phase I portion of the study have demonstrated encouraging safety and efficacy outcomes. While detailed data has not yet been released, these initial findings suggest that the combination of DFP-10917 and venetoclax may offer a promising therapeutic approach for AML patients who have progressed on or are intolerant to venetoclax-based therapies.
Rationale for the Combination
The current standard of care for many AML patients involves a combination of azacitidine and venetoclax. However, this regimen can be challenging for some patients due to its toxicity profile. Delta-Fly Pharma is exploring the DFP-10917 and venetoclax combination as a potentially safer and more tolerable option. The company hopes that this approach could lead to a New Drug Application (NDA) approval from the FDA in the US, potentially through a collaboration with a global pharmaceutical company.
Planned Phase III Study
Delta-Fly Pharma is also planning a Phase III study of DFP-10917 as a monotherapy in patients with relapsed/refractory AML. However, the company notes that the data cut-off for this study may be affected by a decreasing number of long-term survivors in this patient population. Further details regarding the Phase III trial design and timeline will be forthcoming.
