Behind the Phase 1 Study of TAR-210 in FGFR-Altered NMIBC
Antoni Vilaseca Cabo, MD, discusses the rationale behind the phase 1 study evaluating the safety and efficacy of TAR-210 in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer.
Antoni Vilaseca Cabo, MD, adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, discusses the rationale behind the phase 1 study (NCT05316155) evaluating the safety and efficacy of TAR-210 in patients with FGFR-altered high- and intermediate-risk non–muscle invasive bladder cancer (NMIBC), highlighting its methods and design.
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0:09 | We know that even with some available treatments, recurrence rates for patients with NMIBC remain high, highlighting the need for more effective therapies. Activating FGFR alterations are present in about 50% to 80% of patients with advanced bladder cancer, and these are known to be potential oncogenic drivers.
0:35 | We also have a drug, erdafitinib, a selective pan-FGFR tyrosine kinase inhibitor, which has shown good results in metastatic and advanced urothelial carcinoma. It is already approved in the US and other countries for patients following first-line systemic treatment. In a previous study, called THOR-2 [NCT04172675], we observed some activity with systemic use of erdafitinib in NMIBC. However, systemic [adverse] effects were likely too high for this patient population. To address this, a new intravesical drug delivery system has been designed to evaluate the use of erdafitinib locally, aiming to reduce systemic toxicities while maintaining its efficacy.
1:31 | This study has different cohorts and we presented data from cohorts 1 and 3. Cohort 1 included patients with high-risk NMIBC. These were patients with recurrent high-grade TA or T1 papillary tumors, without carcinoma in situ, and all had previously been treated with BCG. Cohort 3 included patients with intermediate-risk NMIBC. These patients had a history of recurrent low-grade TA or T1 disease. All patients in this cohort had visible tumors in the bladder before starting treatment. The study used an accumulation design, and all patients in both cohorts had FGFR alterations identified either in tissue samples or through cell-free DNA from urine.
