Antoni Vilaseca, MD, Hospital Clínic de Barcelona, Spain, shares results from cohorts 1 and 3 in a phase 1 trial evaluating the safety and efficacy of TAR-210, a novel erdafitinib intravesical drug delivery system for patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. TAR-210 provides local, continuous release of erdafitinib within the bladder to limit systemic toxicities.

Of the results, Dr Vilaseca commented, “It’s a very impressive response. We have to see how long it lasts, this response, in these patients, but we’re optimistic on the results.”

Dr Vilaseca first presented these results at the 2023 European Society for Medical Oncology Annual Congress in Madrid, Spain.

Transcript:

Welcome to ESMO 2023. Thank you for coming. My name is Antoni Vilaseca. I'm a urologist from Barcelona, in the Hospital Clínic, and I'm one of co-authors of the TAR-210 abstract that we're presenting in this Congress.

The rationale of doing this study was because in non-muscle invasive bladder cancer we have quite a lack of treatment options for those patients. And we also have a very important oncogenic driver, which is a mutation in FGFR, in the bladder tumor, which is expressed in around 50% to 80% of the patients with this disease. And we have a drug that works against this mutation.

Here in this Congress we present a phase 1 study, a safety and effectiveness study, evaluating the TAR-210 device, which is a device inserted inside the bladder and that releases erdafitinib continuously into the bladder.

We will present 2 cohorts of the study here: cohort 1 is with high-risk non-muscle-invasive bladder cancer with no cys[tectomy]. They're all BCG-experienced and -unresponsive patients not undergoing radical cystectomy. And they all have a complete resection of the tumor before entering the study. We also present the results of the cohort 3, which is intermediate-risk, non-muscle-invasive bladder cancer. That means they are patients that have history of only low-grade disease and, in this case, we do not perform a complete TUR [trans urethral resection] before entering the study, so it's like a chemo-resection study, in this sense.

The results are quite impressive for us. We have this first assessment study of the trial, and in cohort 1 we've seen an 82% response, with patients remaining disease-free. In cohort 3, we have 87% of complete response rate in the first evaluation, in the first assessment.

For us, it's a very impressive response. We have to see how long it lasts, this response, in these patients, but we're quite optimistic on the results.

Source:

Vilaseca A, Jayram G, Raventos C, et al. 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 2023 ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. LBA104