Delta-Fly Pharma Provides Promising Results Of The Phase III Clinical Trial Of DFP-14323 Along With Afatinib

Afatinib, currently being studied along with DFP-14323 in a Phase III clinical trial, has received a significant endorsement in Japan. The Japanese Lung Cancer Society has included Afatinib in its "Lung Cancer Treatment Guidelines 2024," released on October 20, 2024, as a recommended first-line therapy for patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with uncommon mutations. This recommendation surpasses that of Osimertinib, reflecting growing confidence in its efficacy.

The Phase III trial evaluates the combination of DFP-14323 with Afatinib (20 mg/day) against Afatinib alone (40 mg/day) in patients with stage III/IV EGFR mutation-positive uncommon mutation NSCLC. The superiority trial study aims to determine clinical efficacy based on progression-free survival (PFS). The strong recommendation for Afatinib as a first-line treatment is expected to enhance patient enrolment in the ongoing trial.

The trial is being conducted across 30 leading hospitals in Japan, specialising in NSCLC treatment. DFP-14323, a small molecule with an oral absorption rate nearing 100%, targets the CD13/APN receptor commonly found in NSCLC cells, including cancer stem cells. Plans are underway to seek collaboration with a global pharmaceutical partner to further its development and potential global application.