Global pharma giant Johnson & Johnson has announced encouraging results from a Phase 1 study testing its investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate- and high-risk non–muscle-invasive bladder cancer (NMIBC) carrying select FGFR gene alterations. 

 

The open-label, multicenter trial met its primary safety endpoint and showed complete and durable responses in patients with recurrent intermediate-risk disease, alongside promising recurrence-free outcomes in high-risk cases. 

 

FGFR alterations are prevalent in early-stage bladder cancer, appearing in roughly 70% of intermediate-risk and 40% of high-risk NMIBC tumors. These genetic changes can drive tumor growth, making them a key therapeutic target. Erda-iDRS delivers prolonged intravesical release of erdafitinib—a targeted oral kinase inhibitor—directly into the bladder over three months, aiming to provide localized therapy while minimizing systemic side effects.

 

“Intermediate-risk non–muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return,” said Antoni Vilaseca Cabo, adjunct physician of the Urology Service at Hospital Clínic de Barcelona and presenting author. 

 

“In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention.”

 

Christopher Cutie, Vice President and Disease Area Leader, Bladder Cancer, Johnson & Johnson, added: “For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision‑based approaches. The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated.”

 

The results support ongoing Phase 2 and Phase 3 trials of Erda-iDRS across NMIBC risk settings, marking a potential shift toward precision-based therapy in early-stage bladder cancer.