ArticleTherapeutic advances in medical oncology2026
A phase II study of DFP-14323, a non-specific immunomodulator, in combination with low-dose afatinib as first-line therapy for common
Article in Therapeutic advances in medical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Aminopeptidase N (CD13) has been reported to be a prognostic factor in non-small cell lung cancer (NSCLC). DFP-14323 (INN: ubenimex) is a CD13 inhibitor and a low-toxicity, non-specific immunomodulator approved in Japan for the maintenance treatment of adult acute non-lymphocytic leukemia. Objectives: This study explored the potential immunomodulatory synergy of DFP-14323 with EGFR-TKIs in patients with advanced NSCLC. Design: A prospective, multicenter, open-label, single-arm phase II study. Methods: Stage III/IV treatment-naïve patients with activating Results: The DCR as primary endpoint was 100% (95% confidence interval (CI), 86.8-100.0%). Independent radiological review at 72 weeks demonstrated a median progression-free survival (PFS) of 16.6 months (95% CI, 10.2-22.9). Updated investigator-exploratory follow-up revealed a median PFS was 23.1 months (95% CI, 12.9- not estimable; median follow-up period: 22.6 months). One grade 3 paronychia was considered DFP-14323-related, while other adverse events were attributable to afatinib. No grade 4-5 adverse events occurred. Grade 1 interstitial lung disease occurred in one patient and resolved quickly. Conclusions: The combination of DFP-14323 and low-dose afatinib was considered to have the potential for future clinical utility for
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