Dr. Vilaseca highlights study of erdafitinib intravesical delivery system in bladder cancer

In a recent interview, Antoni Vilaseca, MD, PhD, discussed ongoing research exploring TAR-210, an intravesical drug delivery system designed to provide localized continuous release of erdafitinib (Balversa) in patients with bladder cancer.

“All the preliminary studies [of TAR-210 indicated] that it could be a good administration device,” said Antoni Vilaseca, MD, PhD.

Vilaseca, an adjunct physician in the Urology Service at the Hospital Clínic de Barcelona, specifically highlights a first-in-human phase 1 study of TAR-210 (NCT05316155) that was spotlighted during the 2023 ASCO Genitourinary Cancers Symposium.¹ The study is evaluating the safety, efficacy, and pharmacokinetics of TAR-210 in patients with recurrent non–muscle invasive bladder cancer (NMIBC) or MIBC harboring select FGFR mutations or fusions.

What was the rationale for investigating this novel delivery method? How might it address an unmet need?

Vilaseca: We presented a phase 1, first-in-human study on the use of [the] directed, anti-FGFR [agent] erdafitinib administered into the bladder through a device called TAR-210. This is not the only study [evaluating] the target device. The device is inserted into the bladder and delivers the drug continuously [over] a long period of time. In NMIBC, we are used to administering [intravesical] Bacillus Calmette-Guerin [BCG], mitomycin C, and other drugs. We administer them weekly during a period of 6 to 8 weeks, but after 20 to 30 minutes, the patient [has] already released the drug. For the first time, this device is continuously giving the drug until it has to be [replaced, which is at about] 3 months.

All the preliminary studies [of TAR-210 indicated] that it could be a good administration device. The only drawback that we may have foreseen before starting, and that we’re analyzing during the study, is the AEs that [come with] having a strange [device] inside the bladder.

Could you expand on the trial design and the key objectives?

The objective of this study is to look at the safety and tolerability of both the new device and erdafitinib. We must analyze these components continuously during the study period. As a first-in-human study, we have a dose-escalation period to find the toxicity [of] different doses. We have foreseen that they can be toxic. Then, we will [go on to conduct] the second phase of the study.

Do you foresee any challenges with enrollment to this trial?

Enrollment [may not] be easy. We’re talking about a drug that targets a very specific mutation, [one that is] not seen in all patients NMIBC. We expect 60% to 70% of [the population to have] NMIBC, and 30% [to have] MIBC. Patients must have [the FGFR] mutation [to enroll.]

Since the standard of care [SOC] in high-risk NMIBC is cystectomy, we will only be including patients not suitable for cystectomy in this cohort. In the cohort with MIBC, the SOC is adjuvant chemotherapy. Again, we will only be able to include those [who are] not suitable for this SOC treatment.

If data with the TAR-210 delivery system prove to be positive down the line, how could this device impact the treatment paradigm?

This is a phase 1 study, so we’re [mainly] looking at tolerability. If further studies [of TAR-210] are positive, and we find that intravesical delivery is useful for these different patient cohorts, we will have several benefits. The most important one would be [for] cohort 3, [which includes patients] with intermediate-risk cancer and a history of low-grade tumors with recurrence. [By] treating [these patients] with this device, we’re doing less surgeries [or] chemoresection with mitomycin C.

The other [advantage of TAR-210] is [for] those patients not suitable for neoadjuvant chemotherapy [who] have small tumors. The rationale for neoadjuvant chemotherapy is [its] systemic effect. This device with erdafitinib will not have a systemic effect. [However], for select tumors [that are] small or completely resected, we [may] be able to increase the results of the cystectomy with no systemic AEs if there’s local action with the treatment. The AEs we [anticipate] finding will mainly be local, [in response] to having a device inside the bladder.

Reference

1. Vilaseca A, Guerrero F, Zainfield D, et al. Safety and efficacy of the erdafitinib (erda) intravesical delivery system, TAR-210, in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) harboring select FGFR mutations or fusions: Phase 1 first-in-human study.J Clin Oncol. 2023;41(suppl 6):TPS583. doi:10.1200/JCO.2023.41.6_suppl.TPS583