Japan-based pharmaceutical manufacturer Delta-Fly Pharma Inc (TOKYO: 4598) announced on Wednesday that it has commenced patient enrollment for its Phase III clinical trial of DFP-14323 in combination with Afatinib (20 mg/day) versus Afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer (NSCLC) patients with uncommon EGFR mutations.

Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in February 2024, this trial will be conducted at 30 sites in Japan.

The primary endpoint is to confirm the superiority of DFP-14323 in progression-free survival (PFS). DFP-14323 targets aminopeptidase N, which is highly expressed in lung cancer and inflammatory cells, potentially offering effective treatment for refractory cancer patients regardless of EGFR mutation types.

Plans are underway to expand the trial to other Asian countries with high numbers of EGFR mutation-positive NSCLC patients. Delta-Fly Pharma will also seek out-licensing opportunities with Asian pharmaceutical companies.