Delta-Fly Pharma Begins Phase III DFP-14323 Comparative Trial

Delta-Fly Pharma Inc., a pharmaceutical company based in Japan, has made significant strides in the development of a new cancer treatment. The company recently reported the promising results of a Phase II clinical trial at the 2022 ASCO Annual Meeting. The trial involved the use of DFP-14323 in combination with afatinib for patients with stage III/IV non-small cell lung cancer who have a specific epidermal growth factor receptor (EGFR) mutation. The treatment showed a significantly extended median progression-free survival (mPFS) of 23.1 months, which is a notable achievement in the field of cancer therapy.
Following the positive outcomes, Delta-Fly Pharma has been in discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to seek conditional approval for the drug. The company has decided to proceed with a Phase III clinical trial, which will compare the efficacy of DFP-14323 combined with a lower dose of afatinib (20 mg/day) to a higher dose of afatinib (40 mg/day) alone. This decision was made in accordance with the PMDA's advice and is aimed at patients with a less common EGFR mutation.
The company is pleased to announce that the protocol for the Phase III trial has received approval from the PMDA, and they are now prepared to commence the study. The trial is set to take place at 30 locations across Japan. If the trial confirms the superior effectiveness of DFP-14323 in enhancing progression-free survival (PFS), which is the primary endpoint, Delta-Fly Pharma believes that DFP-14323 could become an innovative cancer immunotherapy option. The drug is seen as potentially beneficial due to its oral administration, safety, and cost-effectiveness.
Additionally, the company is exploring the possibility of conducting a comparative study to establish non-inferiority to osimertinib, which could potentially open up a larger market for the drug. Delta-Fly Pharma is also actively engaging in negotiations with other pharmaceutical companies to secure out-licensing opportunities for the drug outside of Japan.
The company is committed to bringing innovative solutions to cancer patients and invites interested parties to learn more about their work.