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DFP-10917 and Venetoclax Combination Trial Advances to Phase II for AML Treatment

• Delta-Fly Pharma's Phase I/II trial evaluating DFP-10917 in combination with Venetoclax has successfully completed the dose-finding phase with positive tolerability results in AML patients.

• The Data Management Committee has approved the safety profile in all six patients from Phase I, enabling progression to Phase II efficacy testing.

• Multiple potential patients are already lined up to participate in the Phase II portion, indicating strong interest in this second-line therapy option for acute myeloid leukemia.

Delta-Fly Pharma announced today that its innovative combination therapy study of DFP-10917 with Venetoclax has successfully completed the Phase I portion and received approval to advance to Phase II efficacy testing in acute myeloid leukemia (AML) patients.
The Phase I/II clinical trial (NCT06382168), focused on second-line therapy for AML patients, demonstrated favorable tolerability results across all six participants in the dose-finding phase. The Data Management Committee (DMC) has reviewed and approved the safety data, marking a significant milestone in the development of this combination treatment approach.

Safety Profile and Trial Progress

The successful completion of the Phase I portion validates the safety profile of combining DFP-10917 with Venetoclax, a well-established AML treatment. The study team reports strong interest in the trial, with multiple potential participants already identified for the Phase II efficacy portion.

Treatment Landscape Context

Acute myeloid leukemia remains one of the most challenging blood cancers to treat, particularly in the second-line setting where treatment options are limited. The combination of DFP-10917 with Venetoclax represents a novel approach to addressing this significant unmet medical need.

Clinical Trial Design

The ongoing Phase I/II study is designed to evaluate both the safety and efficacy of the combination therapy. Following the successful dose-finding phase with six patients, the trial is now transitioning to Phase II, which will focus on determining the treatment's effectiveness in a larger patient population.
The advancement to Phase II, announced on February 28, 2025, marks an important step forward in Delta-Fly Pharma's development program and potentially offers new hope for AML patients who have failed first-line therapy.
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