Delta-Fly Pharma: Phase III Trial Update on DFP-14323

TOKUSHIMA, Japan--(BUSINESS WIRE)--We are thrilled to report significant progress in our latest medical advancement. Afatinib, currently under investigation in our Phase III clinical trial, has been approved by the Japanese Lung Cancer Society. The approval is part of the “Lung Cancer Treatment Guidelines 2024,” released on October 20, 2024, recognizing Afatinib as a first-line treatment for non-small cell lung cancer (NSCLC) with uncommon EGFR mutations. This approval places Afatinib at a higher recommendation level compared to Osimertinib.

The ongoing Phase III clinical trial focuses on patients with stage III or IV NSCLC who have EGFR mutation-positive uncommon mutations. The trial compares the effectiveness of DFP-14323 in combination with two different doses of Afatinib: 20 mg/day and 40 mg/day. The aim is to determine the superiority of the combination treatment over the standalone higher dose of Afatinib.

To ensure comprehensive results, the trial is being conducted across 30 major hospitals in Japan, all specializing in the treatment of NSCLC. The primary endpoint for evaluating clinical efficacy is progression-free survival (PFS). The trial’s design allows us to compare how long patients live without the disease worsening, providing a vital metric for assessing treatment success.

DFP-14323 is a small molecule designed for oral administration, with an absorption rate close to 100%. Its mechanism of action involves inhibiting the CD13/APN receptor, commonly present on NSCLC cells, including cancer stem cells. By targeting this receptor, DFP-14323 aims to hinder the growth and proliferation of these cancerous cells.

This development represents a significant step forward in treating NSCLC, particularly for patients with uncommon EGFR mutations who have limited options. The robust recommendation for Afatinib as a first-line treatment is expected to boost patient enrollment in our ongoing trial, accelerating the collection of data necessary for final analysis.

Our goal is to collaborate with a global pharmaceutical company to further the development of DFP-14323. By combining our innovative approach with extensive resources, we aim to bring effective treatments to patients battling NSCLC worldwide.

We are committed to advancing treatment options for cancer patients and believe that our research has the potential to make a substantial difference in their lives. Our innovative strategies reflect our dedication to addressing the needs of those suffering from this devastating disease.