Delta-Fly Pharma Inc.: Progress Update of the Phase III Clinical Trial of DFP-14323

We are excited to share our latest development status.

Similar to its position in the United States, we are pleased to announce that Afatinib, which is being treated with DFP-14323 in our ongoing Phase III clinical trial, has been approved by the Japanese Lung Cancer Society in its “Lung Cancer Treatment Guidelines 2024” (issued on October 20, 2024) as a first-line treatment for EGFR mutation-positive (uncommon mutation) non-small cell lung cancer (NSCLC), with a stronger recommendation than Osimertinib.

The development of DFP-14323 is being conducted in patients (stage III/IV) with epidermal growth factor receptor (EGFR) mutation-positive uncommon mutation NSCLC in a Phase III clinical trial (superiority study) comparing DFP-14323 in combination with Afatinib (20 mg/day) and Afatinib (40 mg/day) alone. The strongly recommended treatment with afatinib as first-line therapy must accelerate the enrollment of NSCLC patients through this trial.

The study is being conducted at 30 core hospitals throughout Japan involved in the treatment of NSCLC, and clinical efficacy will be finally determined by progression-free survival (PFS). DFP-14323 is a small molecule substance (oral absorption rate of approximately 100%) that inhibits the CD13/APN receptor, which is frequently found on cells in NSCLC including cancer stem cells. We plan to promote it for development collaboration with a global pharmaceutical company.

Please take notice of our own innovative approach for miserable cancer patients and contact us.

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