Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non–Muscle-Invasive Bladder Cancer

What are the outcomes of disitamab vedotin plus tislelizumab for transurethrally unresectable, ERBB2 (formerly HER2)–positive, very high-risk, non–muscle-invasive bladder cancer (VHR NMIBC)? In this single-arm, phase 2, nonrandomized clinical trial including 28 adults, more than half of efficacy-evaluable patients with 2019 European Association of Urology–defined VHR NMIBC achieved complete response (CR) of high-risk disease, meeting the alternative-rate goal, and a similar number exceeded the 17-response threshold in the all-treated analysis. The 24-month sustained response was high, with some grade 3 to 4 treatment-related adverse events reported. Results suggest that disitamab vedotin plus tislelizumab provided a high CR rate and durable disease control in patients with transurethrally unresectable ERBB2-positive VHR NMIBC, and further evaluation of this investigational regimen in randomized clinical trials is recommended.

Corresponding Authors: Hailong Hu, MD (huhailong@tmu.edu.cn), and Chong Shen, MD (shenchong20160806@163.com), Department of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, 23 Pingjiang Rd, Jianshan Street, Hexi District, Tianjin 300211, China.

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