A clinical study of RC48-ADC combined with PD-1 inhibitor in bladder preservation therapy for muscle-invasive bladder cancer (MIBC)-based on real-world data analysis.

Objectives: This study aimed to evaluate the efficacy and safety of RC48-ADC combined with PD-1 inhibitors in bladder preservation therapy for muscle-invasive bladder cancer (MIBC), and to explore the differences in treatment outcomes between primary and recurrent cases, as well as patients at different clinical stages.

Methods: A retrospective analysis was conducted on 32 patients with clinically non-metastatic MIBC who received ≥ 3 cycles of RC48-ADC combined with PD-1 inhibitor therapy. Clinical efficacy was assessed through integrated imaging and histopathological evaluations.

Results: Among the 32 patients, the 1-year progression-free survival (PFS) rate was 84.4%, the objective response rate (ORR) was 68.8%, and the 1-year bladder preservation rate was 68.8%. The primary group was superior to the recurrent group in PFS (94.7% vs. 69.2%), ORR (78.9% vs. 53.8%), and 1-year bladder preservation rate (78.9% vs. 53.8%). Similarly, T2-stage patients exhibited better clinical responses than T3-stage patients in PFS (85.0% vs. 75.0%), ORR (80.0% vs. 54.5%), and 1-year bladder preservation rate (80.0% vs. 54.5%). Treatment-related adverse events (AEs) were predominantly grade I-II, with no severe immune-related complications reported.

Conclusions: The combination of RC48-ADC and PD-1 inhibitors significantly improves bladder preservation rates in MIBC patients with a favorable safety profile, particularly in primary and T2-stage cases. This regimen provides a personalized therapeutic strategy for patients unsuitable for conventional treatments.