Johnson & Johnson highlights first-in-human Erda-iDRS results in intermediate risk non muscle invasive bladder cancer

Johnson & Johnson announce their new results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer whose tumors harbor select fibroblast growth factor receptor alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease.

Note that the FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70 percent of intermediate-risk and 40 percent of high-risk non–muscle-invasive bladder cancer tumors. Because these changes may drive tumor growth, they represent an important therapeutic target in this setting. Erda-iDRS is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment while aiming to minimize systemic exposure and the risk of adverse events associated with oral administration.

“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,* M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, 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.”

“For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision‑based approaches,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. “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.”

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Related Topics and Keywords

bladder cancer, Johnson & Johnson, non–muscle-invasive bladder cancer, TAR-210