New Therapeutic Approach Improves Outcomes in Advanced Bladder Cancer

Muscle-invasive bladder cancer is an advanced form of bladder carcinoma in which the tumor has penetrated the muscle layer of the bladder wall. Compared to non-muscle-invasive tumors, the risk of metastasis is higher, which is why radical removal of the bladder (cystectomy) is usually required as the primary treatment.

A new international study involving Dresden University Medicine demonstrates promising advances in the treatment of muscle-invasive bladder cancer. Until now, chemotherapy with cisplatin and gemcitabine prior to surgical bladder removal has been the standard of care. In the KEYNOTE-B15 study, which included 808 patients, this standard treatment was compared with a combination of the targeted agent enfortumab vedotin and the immunotherapy pembrolizumab.

The results show that significantly more patients in the new treatment group had no detectable tumor after surgery (55.8 percent versus 32.5 percent). Patients receiving the combination therapy also lived longer without disease recurrence, and overall long-term survival improved. While skin reactions and peripheral neuropathy occurred more frequently with the new combination, classic chemotherapy-related side effects such as low white blood cell counts were less common.

“The nearly doubled rate of complete tumor responses is a very strong signal that we can fundamentally improve the treatment of muscle-invasive bladder cancer,” summarizes Privatdozentin Dr. Katharina Böhm, Senior Physician at the Department of Urology at University Hospital Dresden and Deputy Head of the Uro-Oncology Center.

These findings point to a paradigm shift in urologic oncology: away from chemotherapy alone toward combined targeted and immunotherapy approaches, even in earlier stages of the disease. Given that more than half a million new cases are diagnosed worldwide each year, with a significantly higher incidence in men, this development also has major societal relevance. At the same time, the study underscores the importance of close interdisciplinary care to ensure early detection and management of side effects.

The Uro-Oncology Center at the National Center for Tumor Diseases (NCT/UCC) Dresden played a key role in the study as a “high recruiter,” enrolling 15 patients. The study is sponsored by Merck Sharp & Dohme (MSD) in collaboration with Astellas and Pfizer, who are jointly developing enfortumab vedotin in combination with pembrolizumab.

Study: “Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study.” https://ascopubs.org/doi/10.1200/JCO.2026.44.7_suppl.LBA630

Authors: Matthew D. Galsky, Begoña P. Valderrama, Marco Maruzzo, Albert Font Pous, Tudor-Eliade Ciuleanu, Jonathan Alexander Chatzkel, Takuya Koie, Christopher J. Hoimes, Javier Puente, Yousef Zakharia, Eli Rosenbaum, Katharina Boehm, Yohann Loriot, Jens Bedke, Heidi Wirtz, Mike Mihm, Qinlei Huang, Josh Rogiers, Blanca Homet Moreno, Alfonso Gomez De Liaño Lista

Scientific contact:
PD Dr. med. Katharina Böhm
Senior Physician, Department of Urology, FEBU
katharina.boehm@ukdd.de

Media contact:
Anne-Stephanie Vetter
Staff Unit Public Relations of Carl Gustav Carus Faculty of Medicine 
at TUD Dresden University of Technology
National Center for Tumor Diseases (NCT/UCC) Dresden
Tel.: +49 (0) 351 458 17903
anne-stephanie.vetter@tu-dresden.de