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.
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.
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.
GlobalData is the parent company of Clinical Trials Arena.
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.
