TAR-210 demonstrates initial safety and efficacy in patients with NMIBC

Findings from a phase 1 study (NCT05316155) exploring TAR-210 showed initial safety and efficacy for the erdafitinib (Balversa) intravesical delivery system in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.

"We look forward to further results from this study in the future and the ongoing development of the localized delivery of erdafitinib," Antoni Vilaseca, MD, PhD.

The data were presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain.¹

Results showed a recurrence-free survival (RFS) rate of 82% (9/11) among patients included in cohort 1 of the study (patients with FGFR-altered high-risk NMIBC) who had a response assessment. The median duration of treatment exposure was 3.7 months, with the first response assessment taking place at 3 months. At the time of data cutoff, the median RFS had not yet been met (95% CI, 2.96 months – NE).

In patients in cohort 3 (patients with FGFR-altered intermediate-risk NMIBC) with a response assessment, the complete response rate (CR) was 87% (13/15). The median duration of treatment was 4.2 months. The median duration of response had not yet been met at the time of data cutoff (95% CI, NE – NE). All CRs remain ongoing.

Treatment with TAR-210 was also associated with sustained erdafitinib concentrations in the urine over 90 days with very low plasma concentrations. No hyperphosphatemia was observed.

The investigators also observed no dose-limiting toxicities or deaths among all patients. In total, 2 patients discontinued treatment due to adverse events (AEs) related to low-grade urinary symptoms. Serious AEs of pyelonephritis and sepsis were observed in 1 patient and were not related to treatment.

All patientsincluded in the study were divided into 4 cohorts based on their disease presentation. Cohort 1 includes patients with recurrent, BCG-unresponsive high-risk NMIBC with concomitant high-grade papillary disease and who have refused or are ineligible for radial cystectomy. Cohort 2 includes patients of the same disease presentation as cohort 1, but who are scheduled to undergo radical cystectomy. Cohort 3 includes patients with recurrent, intermediate-risk NMIBC who have a history of low-grade papillary disease and have a visible tumor present. Cohort 4 of the study includes patients with muscle-invasive bladder cancer.

At the time of data cutoff, 16 patients in cohort 1 and 27 patients in cohort 3 had been treated with TAR-210, which were reported at ESMO. The median patient age in cohort 1 was 73.5 years, and the median patient age in cohort 3 was 67 years.

The primary end point of the study is safety, including AEs and dose-limiting toxicities. Secondary end points include pharmacokinetics, RFS in patients in cohorts 1 and 2, CR rate and the duration of CR in patients in cohort 3, and the pathological CR rate in patients in cohort 4.

Presenting author Antoni Vilaseca, MD, PhD, of the Hospital Clínic de Barcelona, concluded in a news release on the findings, "Patients with high- or intermediate-risk non-muscle-invasive bladder cancer have seen limited advancement in the treatment landscape over the [p]ast 50 years, and the available options are associated with a high risk of recurrence and significant [adverse] effect burden. We look forward to further results from this study in the future and the ongoing development of the localized delivery of erdafitinib.”²

References

1. First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non-muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt). Presented at the European Society of Medical Oncology (ESMO) Congress. October 20-24, 2023. Madrid, Spain. Abstract LBA104

2. First results with erdafitinib-releasing intravesical delivery system (TAR-210) show early evidence of positive clinical activity in patients with non-muscle-invasive bladder cancer with select fibroblast growth factor receptor alterations. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. October 22, 2023. Accessed October 26, 2023. https://www.prnewswire.com/news-releases/first-results-with-erdafitinib-releasing-intravesical-delivery-system-tar-210-show-early-evidence-of-positive-clinical-activity-in-patients-with-non-muscle-invasive-bladder-cancer-with-select-fibroblast-growth-factor-receptor-al-301963787.html