The Phase III superiority study will evaluate the combination therapy of Delta-Fly Pharma’s DFP-14323 and Giotif in comparison with Giotif monotherapy. Image Credit: Cozine / Shutterstock.

Japanese company Delta-Fly Pharma has received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a Phase III trial for the combination treatment of DFP-14323 and Boehringer Ingelheim’s Giotrif (afatinib).

The Phase III superiority study will evaluate the combination therapy of DFP-14323 and Giotif in comparison with Giotif monotherapy in patients with stage III/IV NSCLC with uncommon epidermal growth factor receptor (EGFR) mutation.

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The primary endpoint of the trial is the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS). The study will be conducted at 30 sites across Japan.

The company is also negotiating out-licensing opportunities for the territory outside Japan with pharmaceutical companies, as per a 2 February press release.

DFP-14323 consists of a low dose of ubenimex, a competitive, reversible protease inhibitor, with an enhanced antitumour effect and improved immune function. The single-arm Phase II trial (UMIN000033062) of the drug showed a median PFS of 23.1 months with combination therapy.

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There are more than 1.5 million diagnosed prevalent cases of NSCLC in 16 countries including Japan, as per a GlobalData report. Japan is also expected to represent 15% of the global burden of the disease in 2027.

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Another treatment being evaluated in patients with advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R substitution includes Johnson & Johnson’s Rybrevant (amivantamab-vmjw), an EGFR and mesenchymal-epithelial transition (MET) targeting bispecific antibody. The findings from the Phase III MARIPOSA-2 trial (NCT04988295) showed Rybrevant plus chemotherapy, reduced disease progression or mortality risk by 56%, compared with chemotherapy alone.

AbbVie’s Teliso-V (telisotuzumab-vedotin) demonstrated a clinically meaningful overall response rate (ORR) in a Phase II LUMINOSITY trial (NCT03539536) of patients with advanced or metastatic NSCLC. Teliso-V is an investigational first-in-class, c-Met protein-directed antibody-drug conjugate. Teliso-V showed an ORR of 35% in c-Met High patients and 23% in c-Met Intermediate patients.