Delta-Fly Pharma Inc. has announced promising initial data 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 currently enrolling patients in its Phase I portion.
The first three patients enrolled in the Phase I portion of the study have demonstrated encouraging safety and efficacy results, suggesting potential for further development of this combination therapy. This approach is being explored as a potentially safer alternative to the existing standard combination chemotherapy of azacitidine and venetoclax, which can be challenging for AML patients.
Rationale for DFP-10917 and Venetoclax Combination
The current standard treatment for AML often involves a combination of azacitidine and venetoclax. Delta-Fly Pharma is pursuing a combination of DFP-10917 with venetoclax with the goal of providing a safer treatment option. The company is aiming for objective NDA approval from the FDA in the US, potentially through collaboration with a global mega-pharmaceutical company.
Planned Phase III Study
Delta-Fly Pharma is also planning a Phase III study of DFP-10917 in patients with relapsed or refractory AML. The data cut-off for this study is planned in consideration of the decreasing number of long-term survivors in this patient population.
