Conference Report: In-depth Academic Analysis
Editor’s Note: During the recent academic conference, Professor Liangyou Gu from the People’s Liberation Army General Hospital (PLAGH) presented the latest findings from a prospective, controlled, phase II study. The study evaluated the efficacy and safety of Disitamab Vedotin (DV/RC48), a HER2-targeted antibody-drug conjugate (ADC), combined with Tislelizumab (a PD-1 inhibitor) as adjuvant therapy for patients with HER2-expressing upper tract urothelial carcinoma (UTUC) following radical surgery.
01 Background: Significant Clinical Gap in UTUC Adjuvant Therapy
Upper tract urothelial carcinoma (UTUC) is a relatively rare but aggressive malignancy. While radical surgery followed by adjuvant chemotherapy is the current standard of care, a substantial proportion of patients are “cisplatin-ineligible” due to advanced age or impaired renal function (low eGFR). Additionally, some patients refuse conventional chemotherapy due to toxicity concerns. Research indicates that HER2 is expressed in up to 80% of urothelial carcinoma cases, with high expression often correlating with a poorer prognosis. Building on the success of the RC48-C016 study, which demonstrated the benefit of DV plus immune checkpoint inhibitors (ICIs) in advanced disease, exploring this combination in the adjuvant setting is of critical clinical importance.
02 Study Design: Focusing on HER2 Expression and Cisplatin-Ineligible Populations
This prospective, controlled, phase II clinical trial enrolled patients with locally advanced, pathologically confirmed UTUC and positive HER2 expression post-radical surgery. • DVT Group (Experimental): Cisplatin-ineligible patients or those who refused chemotherapy received Disitamab Vedotin combined with Tislelizumab. • GC Group (Control): Cisplatin-eligible patients received Gemcitabine plus Cisplatin. The primary endpoint was Disease-Free Survival (DFS), while secondary endpoints included Overall Survival (OS) and safety.
03 Efficacy Data: DVT Regimen Shows Superior DFS Benefit
As of February 4, 2026 (based on the data presented), 74 patients were enrolled, including 40 in the DVT group and 34 in the GC group. • Baseline Characteristics: The mean estimated glomerular filtration rate (eGFR) in the DVT group was significantly lower than that in the GC group, consistent with the typical profile of a cisplatin-ineligible population. • DFS Outcomes: Preliminary results indicated that despite differences in follow-up duration, the 1-year DFS rate in the DVT group was significantly higher than that in the GC group. These findings suggest that the ADC plus immunotherapy combination has robust potential to reduce recurrence in HER2-expressing UTUC.
04 Safety Profile: Manageable with No Unanticipated Risks
Both regimens were well-tolerated, and no treatment-related deaths were observed in either group. • Incidence of Treatment-Related Adverse Events (TRAEs): 92.0% in the DVT group vs. 97.1% in the GC group. • Safety Characteristics: The safety profile of the combination therapy was consistent with previous reports, with most adverse events being clinically manageable and not significantly increasing the overall treatment burden.
05 Conclusion and Outlook: A New Chapter in “Chemo-Free” Adjuvant Strategies
Professor Liangyou Gu concluded that Disitamab Vedotin plus Tislelizumab demonstrates promising efficacy and a manageable safety profile as an adjuvant therapy for HER2-expressing UTUC. For patients who cannot tolerate standard chemotherapy or those with high HER2 expression, this combination regimen may offer a powerful alternative. The team anticipates that further validation through large-scale, randomized controlled Phase III trials will further optimize the adjuvant treatment pathway for UTUC patients in China.
