A system to deliver the targeted therapy erdafitinib directly into the bladder produced high and lasting response rates in patients with certain early-stage bladder cancers, according to a press release published recently by the manufacturer of the drug, Johnson and Johnson.
Erdafitinib (marketed as Balvera) is an oral medication that inhibits the action of a protein called fibroblast growth factor receptor (FGFR), which is involved with the growth of cancer cells and has been altered in many patients with bladder cancer. The investigational drug-releasing system, known as Erda-iDRS, uses a device placed in the bladder to release erdafitinib over a three-month period. By delivering the medication directly to the tumor site instead of orally, the approach is designed to maintain effective drug levels in the bladder while limiting exposure throughout the rest of the body. This may help reduce systemic side effects compared with oral treatments.
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Results from a Phase 1 study showed that the investigational system achieved an 89% complete response rate in patients with intermediate-risk non–muscle-invasive bladder cancer whose tumors carried specific FGFR genetic alterations. Among those who responded, the median duration of response reached 18 months, indicating that tumor control was often sustained well beyond initial treatment.
“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,” said Dr. Christopher Cutie, vice president and disease area leader for bladder cancer at Johnson and Johnson.
In the study, 62 patients with intermediate-risk disease and 26 with high-risk disease received treatment. In the high-risk group, the median recurrence-free survival was 20 months, with 83% of patients remaining recurrence-free at 12 months. These findings suggest the therapy may also help delay tumor return in more aggressive cases.
Treatment was generally well tolerated. The most common side effects were blood in the urine, reported in 32% of patients, and painful urination in 22%. More severe treatment-related side effects occurred in 5% of patients. Nine percent discontinued treatment due to side effects, and 2% experienced serious adverse events. Importantly, drug levels remained largely confined to the bladder, with no observed increase in phosphate levels in the blood.
Larger ongoing Phase 2 and Phase 3 trials will determine whether this approach can become a standard option, particularly for patients whose tumors carry FGFR alterations.
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