▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced positive results from the Phase 1 trial of its investigational intravesical targeted release therapy TAR-210 for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) whose tumors carry specificFGFRGene Mutation.

The trial announced this time is an open-label, multi-center, multi-cohort Phase 1 study. The data includes the latest data from Cohort 1 (C1) and Cohort 3 (C3). Cohort 1 consists of recurrent, Bacillus Calmette-Guérin (BCG) unresponsive, high-risk (HR) NMIBC patients who refused or were unsuitable for radical cystectomy. Cohort 3 includes recurrent, intermediate-risk NMIBC patients.

As of March 22, 2024, 64 patients in the two groups had received TAR-210 treatment.In the C1 group, the 12-month recurrence-free (RF) survival rate was 90% among 21 HR-NMIBC patients. In the C3 group, 31 patients were evaluable for efficacy, with a complete response (CR) rate of 90%.

The most common treatment-emergent adverse events (TEAEs) were grade 1/2 lower urinary tract events. No dose-limiting toxicities were observed, and no patient deaths occurred.

Image Source: 123RF

TAR-210It is a new type of intravesical drug delivery system, a long silicone tube that can deliver very low doses over an extended period.Continuous Local ReleaseFGFR Kinase Inhibitor Balversa (erdafitinib).Balversa is a once-daily FGFR kinase inhibitor.Approximately 20% ofTurnMetastaticUrineCutaneous CarcinomaPatient carriesFGFRGene mutation, Balversa achieves therapeutic effects by inhibiting FGFR. This therapy received the FDA's Breakthrough Therapy Designation (BTD) in 2018, and was granted accelerated approval by the FDA in April 2019, andReceived US FDA approval in January this yearFull Approval, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who haveFGFR3Genetic variation and disease progression after at least one line of systemic treatment.

References:

[1] TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively. Retrieved May 6, 2024 from https://www.prnewswire.com/news-releases/tar-210-results-show-90-recurrence-free-survival-and-90-complete-response-in-patients-with-high-risk-and-intermediate-risk-nonmuscle-invasive-bladder-cancer-respectively-302135657.html

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