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Life sciences · Journal article
Frontiers in Immunology · September 28, 2026
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Objective To assess the efficacy and safety of neoadjuvant RC-48 combined with a PD-1 inhibitor in patients with muscle-invasive bladder cancer (MIBC), and to investigate the stratification utility of HER2 expression and tumor-associated tertiary lymphoid structures (TLS) as predictive variables for treatment response and clinical prognosis. Patients and methods This multicenter retrospective real-world study enrolled 38 patients with MIBC from the First Affiliated Hospital of Nanchang University, the Second Affiliated Hospital of Nanchang University, Jiangxi Cancer Hospital, and Jiangxi Provincial People’s Hospital. All patients received at least four cycles of neoadjuvant therapy comprising RC-48 combined with a PD-1 inhibitor, followed by radical cystectomy (RC). The TLS in the pre-treatment specimens was evaluated using hematoxylin-eosin (HE) staining, and the expression level of HER2 was assessed by immunohistochemistry (IHC) method. The primary endpoint was the pathological complete response (pCR) rate, and secondary endpoints included radiographic complete response (CR) rate, disease-free survival (DFS), and overall survival (OS). Results Among the 38 patients, the pCR rate was 34.2%, and the overall CR rate by radiographic assessment was 36.8%, with a PR rate of 31.6%. After a median follow-up of 18.0 months (range, 9–29 months), the 12-month DFS rate was 89.4% (95% CI: 74.2%–95.9%), and the 12-month OS rate was 100% (95% CI: 100%–100%). HER2 overexpression was significantly associated with a higher objective response rate (ORR) (OR = 22.50, 95% CI: 1.51 - 335.33, p = 0.024). In stratified analyses based on TLS, both TLS-2 (primary lymphoid follicles) and TLS-3 (secondary lymphoid follicles with germinal centers) demonstrated significant associations with higher ORR, with ORs of 20.00 (95% CI: 2.75 - 145.48, p = 0.003) and 36.00 (95% CI: 2.72 - 476.21, p = 0.007), respectively, suggesting that greater TLS with enhanced therapeutic benefit. Furthermore, N1 stage (OR = 0.06, 95% CI: 0.01 - 0.59, p = 0.016), N2 stage (OR = 0.04, 95% CI: 0.00 - 0.62, p = 0.021), and T3 stage (OR = 0.08, 95% CI: 0.01 - 0.46, p = 0.004) were each significantly associated with poorer treatment response. Treatment-related adverse events (TRAEs) were generally manageable. Conclusions The combination of RC-48 and a PD-1 inhibitor exhibits promising efficacy as a neoadjuvant therapy for MIBC. Both HER2 expression and TLS maturity serve as effective stratification indicators for treatment response and prognosis. These findings support further evaluation of this combined regimen in biomarker-driven prospective trials.