At #EAU25, Dr. Seth Lerner (Baylor College of Medicine) presented early findings from a Phase 1 study (NCT05483868) evaluating Bel-sar (AU-011)—a novel virus-like drug conjugate (VDC) for non-muscle invasive bladder cancer (NMIBC).
In this first-in-human trial, a single focal dose of Bel-sar with light activation was delivered during cystoscopy. The treatment was well tolerated, with no drug-related grade ≥2 AEs.
Among efficacy-evaluable patients, clinical complete response was achieved in 4 of 5 low-grade tumors, with immune responses also observed in untreated lesions—demonstrating a powerful urothelial field effect. Histology revealed strong CD4+/CD8+ T-cell infiltration and lymphoid follicle formation.
These results position Bel-sar as a function-preserving, immune-ablative approach with potential to transform NMIBC care. Further studies are underway.
For more information: https://lnkd.in/dbd7riSp
