Delta-Fly Pharma has commenced the enrolment of subjects in the Phase III clinical trial of DFP-14323 for the treatment of non-small cell lung cancer (NSCLC).

The study is designed to evaluate DFP-14323 in combination with Afatinib at a daily dose of 20mg, compared to a 40mg daily dose of Afatinib alone.

It will enrol stage III/IV NSCLC patients in Japan who test positive for uncommon EGFR mutations.

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) granted approval for this trial in February 2024.

It will be carried out across 30 Japanese sites, involving NSCLC specialists.

The primary endpoint of the trial is to validate the superiority of the add-on effect of the therapy on progression-free survival (PFS).

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DFP-14323 has a selective binding mechanism to aminopeptidase N, which is prevalent in various cells, including lung cancer and inflammatory cells.

The asset’s efficacy is anticipated to benefit patients with refractory cancer. If the trial confirms the add-on effect’s superiority, DFP-14323 could emerge as a new cancer immunotherapy, effective regardless of EGFR mutation type.

In a media statement, Delta-Fly Pharma said: “We will accelerate the progress of the trial by expanding this Phase III clinical trial outside of Japan to Asian countries with large numbers of EGFR mutation-positive non-small cell lung cancer patients, and at the same time, we will promote out-licensing activities to Asian pharmaceutical companies.”

In April this year, Delta-Fly Pharma announced the US Food and Drug Administration’s (FDA) approval for a Phase I/II clinical trial protocol to assess DFP-10917 in combination with Venetoclax (VTX) in patients with acute myeloid leukaemia (AML) who have previously been treated with VTX.

The upcoming Phase I/II combo study will investigate whether DFP-10917 combined with VTX is superior to the standard chemotherapy regimen of azacitidine with VTX for AML treatment.