The Annual European Association of Urology Congress 2026 (EAU Congress 2026), one of the world’s premier urological events, was held in London, the United Kingdom, from March 13 to 16, 2026 (UTC+0).
At the congress, results of multiple researches on disitamab vedotin (DV), a HER2-targeted antibody-drug conjugate (ADC), were released, highlighting transformative advances in the treatment of urothelial carcinoma (UC). These studies, all conducted in China, spanned full spectrum of UC, from bladder cancer to upper urinary tract urothelial carcinoma across early to advanced stages, providing high-quality new evidence supporting targeted therapies and organ-preserving strategies.
01
High-Risk Non-Muscle-Invasive Bladder Cancer:
DV Demonstrates Bladder-Preserving Potential Across Local and Systemic Treatment Settings
Significant unmet needs persist in the treatment landscape of high-risk non-muscle- invasive bladder cancer (HR-NMIBC). In the real-world multicenter study led by Professor Cuijian Zhang from Peking University First Hospital, DV alone or combined with PD-1 inhibitor demonstrated favorable efficacy and manageable safety profile in patients with HER2-expressing HR-NMIBC. Among the 32 participants assessed, the objective response rate (ORR) was 81.3%, with a complete response (CR) rate of 71.9% and a 6-month cystectomy-free rate of 71.9%, positioning DV as a promising bladder-preserving treatment option for patients who were Bacillus Calmette–Guérin (BCG)-ineligible or -unresponsive.
A phase Ⅰ study led by Professor Tianxin Lin and Professor Xu Chen from Sun Yat-sen Memorial Hospital, Sun Yat-sen University evaluated the safety and preliminary efficacy of intravesical DV therapy in patients with BCG-unresponsive HR-NMIBC. Results showed that DV was well tolerated with no dose-limiting toxicities or grade 3-4 treatment-related adverse events (TRAEs) observed. The 6-month and 12-month recurrence-free survival (RFS) rates were 81.5% and 61.1% respectively, reinforcing the potential of DV as a novel local treatment approach for HR-NMIBC.
Additionally, a phase Ⅲ study HERO will be initiated by Professor Dingwei Ye and Professor Yijun Shen from Fudan University Shanghai Cancer Center to further explore the efficacy and safety of DV plus BCG versus BCG alone in treatment-naive patients with HR-NMIBC.
02
Bladder-Preserving Treatment for Muscle-Invasive Bladder Cancer:
Final Results of HOPE-03 Study Revealed Long-Term Efficacy and Encouraging Bladder Preservation Rate
Radical cystectomy significantly impacts quality of life in patients with muscle-invasive bladder cancer (MIBC). At this congress, final results were unveiled for HOPE-03, a phase Ib/II study evaluating DV-tislelizumab neoadjuvant treatment followed by radiotherapy-based bladder-sparing therapy in patients with MIBC. The study was led by Professor Peng Zhang and Professor Yali Shen from West China Hospital of Sichuan University.
A total of 59 patients with HER2-expressing (IHC ≥1+) locally advanced MIBC were enrolled. The combination therapy of DV plus a PD-1 inhibitor achieved a clinical complete response (cCR) rate of 64.4% and an ORR of 91.5%. Among the 42 evaluable patients who received the radiotherapy-based bladder-sparing therapy, the cCR rate reached 95.5%. After a median follow-up duration of 24.3 months, the 12- and 24-month event-free survival rates were 92.8% and 89.4%. Notably, all surviving patients maintained their bladder, resulting in a bladder preservation rate of 100%. The incidence of grade 3-4 TRAEs was 12.1%, with no treatment-related death. The HOPE-03 study demonstrated that the DV-tislelizumab neoadjuvant treatment followed by radiotherapy-based bladder-sparing therapy may deliver significant tumor downstaging and long-term organ preservation for patients with locally advanced MIBC.
03
Metastatic Urothelial Carcinoma:
Real-World Study Reaffirms Favorable Efficacy and Manageable Safety of ADC Plus PD-1 Inhibitor as First-Line Therapy
A multicenter real-world study led by Professor Jianhui Chen from Fujian Medical University Union Hospital was presented at the congress, reinforcing the potential of an ADC combined with a PD-1 inhibitor as first-line therapy for metastatic urothelial carcinoma (mUC). This retrospective study included 63 patients with mUC who received DV plus PD-1 inhibitors as first-line therapy. The results showed an ORR of 71.4%, a disease control rate (DCR) of 87.3%, and a median progression-free survival (PFS) of 10.5 months. The median overall survival (mOS) was not reached. The most common TRAEs included fatigue, anemia, and pruritus. The incidence of grade 3 or higher TRAEs was 11.1%, with no grade 4 or 5 events observed. The study reconfirmed the favorable efficacy and manageable safety of the combination therapy as a first-line treatment for mUC in a real-world setting.
04
Upper Tract Urothelial Carcinoma:
Breakthrough Demonstrated Across Adjuvant Treatment and Nephron Preservation Strategy
Adjuvant treatment options for upper tract urothelial carcinoma (UTUC) remain limited. A prospective phase Ⅱ study led by Professor Liangyou Gu from Chinese People's Liberation Army (PLA) General Hospital showed that the efficacy of DV plus tislelizumab is superior to chemotherapy as adjuvant treatment in patients with HER2-expressing UTUC. As of the data cutoff date (February 4, 2026), the 12-month disease-free survival (DFS) rate was 97.4% in the DV plus tislelizumab group versus 82.4% in the chemotherapy group. The incidence of grade 3-4 adverse events was lower in the experimental group, indicating superior safety of the DV-tislelizumab combination therapy.
A phase Ⅱ study led by Professor Xuesong Li, Professor Xiaoying Li and Professor Qi Tang from Peking University First Hospital investigated the safety and efficacy of DV plus radiotherapy as adjuvant treatment in patients with UTUC. Preliminary results showed that, at the median follow-up duration of 11.4 months, the one-year DFS rate was 93.3% in the adjuvant treatment group, compared with 72.7% in the surveillance group.
In the setting of organ preservation, the DISTINCT-I study led by Professor Jiwei Huang from Renji Hospital, Shanghai Jiao Tong University School of Medicine investigated a novel "induction treatment+nephron-sparing surgery" paradigm. The study enrolled 20 patients with high-risk UTUC who received 2–4 cycles of DV+tislelizumab induction therapy followed by kidney-sparing surgery. The one-year kidney intact event-free survival rate was 70%, and the cCR rate was 25.0% after completion of induction therapy, which increased to 75.0% after the subsequent kidney-sparing surgical procedures. The study also showed correlation between tumor response and HER2 expression level, supporting further biomarker validation.
Conclusion
The studies on DV presented by Chinese researchers at this congress reinforced the manageable safety and favorable efficacy profile of DV as intravesical or (neo)adjuvant treatment or as the first-line therapy for patients with UC at various stages. In addition, DV-containing bladder- and nephron-sparing strategy demonstrated compelling tumor downstaging and organ preservation rate, establishing it as a promising new option for patients who are not eligible for the traditional chemotherapy or who seek to maintain a high quality of life. These findings underscored a paradigm shift toward precise and targeted therapies in the management of UC.
