Early Data Shows Promise of TAR-210 in FGFR-Altered NMIBC

Antoni Vilaseca Cabo, MD, adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, discusses phase 1 (NCT05316155) data presented during the 2024 American Urological Association Annual Meeting which looked at the early clinical activity of TAR-210, the erdafitinib (Balversa) intravesical delivery system, for the treatment of patients with FGFR-altered high- and intermediate-risk non-muscle invasive bladder cancer (NMIBC).

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0:09 | The trials are very encouraging. In cohort 1, there were patients with high-risk NMIBC, [and] we estimated a 12-month recurrence-free rate of 90%. The median follow-up at that point is 8.9 months, and only 2 patients out of the 21 patients treated have recurred. In cohort 3, the chemoablation design study of this intermediate-risk NMIBC, 31 patients have been treated until now and assessed for results. And we have a complete response of 90% at week 12. Just to let you know, all the patients, 100% of the patients, had at least nonprogressive disease. So if they did not have a complete response, they had a non complete response but non progressive disease, and 86% of the patients that had a complete response in the first assessment at 12 months are still recurrence-free at the time of the clinical cutoff.

1:23 | Well, these results are very encouraging because oncologically, erdafitinib intravesical delivery is very useful. It has a high rate of responses on our patients, and the most important thing, probably, of this study is that there are no systemic [adverse] effects. Actually, what we also see in the study is that we get sustained release of erdafitinib within the bladder with very high concentrations of erdafitinib in the urine, and with very low concentrations of the drug in the blood, so there are no systemic [adverse] effects in our patients. The thing is that we can have some [adverse] effects locally because we are using this pretzel-shaped device, putting it into the bladder, and you can get some grade 1, grade 2 low urinary tract symptoms, mainly some infections because of the of the manipulation, but there are no systemic toxicities, which is probably the most important thing that we can see in this study.