Delta-Fly Pharma Inc. has announced a progress update on its Phase III clinical trial evaluating DFP-14323 in combination with Afatinib for patients with epidermal growth factor receptor (EGFR) mutation-positive, uncommon mutation non-small cell lung cancer (NSCLC). The trial, a superiority study, compares the combination of DFP-14323 and Afatinib (20 mg/day) against Afatinib (40 mg/day) alone in stage III/IV NSCLC patients.
The Japanese Lung Cancer Society's "Lung Cancer Treatment Guidelines 2024," issued on October 20, 2024, has given Afatinib a strong recommendation as a first-line treatment for EGFR mutation-positive (uncommon mutation) NSCLC, surpassing Osimertinib. This endorsement is expected to accelerate patient enrollment in Delta-Fly Pharma's ongoing trial.
The Phase III study is being conducted across 30 core hospitals in Japan specializing in NSCLC treatment. The primary endpoint for determining clinical efficacy is progression-free survival (PFS). DFP-14323 is a small molecule with approximately 100% oral absorption that inhibits the CD13/APN receptor, a target frequently found on NSCLC cells, including cancer stem cells. Delta-Fly Pharma intends to pursue development collaboration with a global pharmaceutical company to further advance DFP-14323.
Significance of Afatinib Recommendation
The updated Lung Cancer Treatment Guidelines reflect the growing recognition of Afatinib's efficacy in treating specific EGFR mutations in NSCLC. This recommendation underscores the importance of targeted therapies in addressing the diverse genetic profiles of lung cancers. The trial design, comparing DFP-14323 in combination with Afatinib against Afatinib alone, aims to demonstrate the added benefit of DFP-14323 in improving patient outcomes.
About DFP-14323
DFP-14323 is an orally available small molecule designed to inhibit the CD13/APN receptor. This receptor is often overexpressed in NSCLC cells, including cancer stem cells, suggesting a potential role in tumor growth and metastasis. By targeting CD13/APN, DFP-14323 aims to disrupt key pathways involved in cancer progression, offering a novel approach to NSCLC treatment.
Trial Design and Endpoints
The ongoing Phase III trial is a superiority study comparing DFP-14323 in combination with Afatinib (20 mg/day) to Afatinib (40 mg/day) alone. The study includes patients with stage III/IV NSCLC harboring uncommon EGFR mutations. The primary endpoint is progression-free survival (PFS), a critical measure of treatment efficacy in cancer clinical trials. Secondary endpoints may include overall survival, objective response rate, and safety assessments.
