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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

May 5, 2024 – Clinical Trials, Drug Discovery – Janssen, Johnson & Johnson, Johnson & Johnson Innovative Medicine, bladder cancer, clinical trials

Updated results reinforce the potential of TAR-210 to transform treatment of non-muscle-invasive bladder cancer with fibroblast growth factor receptor (FGFR) alterations

5 May 2024 — Beerse, Belgium — Janssen-Cilag International, a Johnson & Johnson company, announced today updated results from an open-label, multicentre, multi-cohort phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non-muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. This data was featured today in an Oral Presentation Session (Abstract #PD48-02) at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas, US.

Results featured updated data from Cohort 1 (C1); patients with recurrent, Bacillus Calmette-Guérin (BCG)-unresponsive high-risk (HR) NMIBC (high-grade Ta/T1; papillary only) who refused or were ineligible for radical cystectomy and Cohort 3 (C3); patients with recurrent, intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease left in situ as tumour marker lesions. First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.

“Advancement in the treatment landscape of high or intermediate-risk non-muscle-invasive bladder cancer has remained stagnant for more than 50 years,” said Antoni Vilaseca MD PhD, of the Hospital Clínic de Barcelona, presenting author of the phase 1 TAR-210 study. “Results presented today further underscore that TAR-210 for the localised treatment of bladder cancer may offer a promising alternative for patients with limited treatment options.”

At the data cut-off of 22 March 2024, 64 patients had been treated with TAR-210 across the two cohorts. Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence free (RF) survival rate was 90% (95 percent confidence interval (CI), 66-97). In C3, 31 patients were efficacy evaluable with 28/31 achieving a complete response (CR) rate of 90% (95% CI, 74-98).

The most common treatment-related emergent adverse events (TEAEs) were Grade 1/2 lower urinary tract events. There were no dose-limiting toxicities and no deaths. Two patients (3%) discontinued the study due to TEAEs of low-grade urinary symptoms and two patients had serious TEAEs with pyelonephritis and sepsis or UTI (urinary tract infection) and sepsis, respectively.

“FGFR genetic alterations are most common in NMIBC,” said Sabine Brookman-May MD, vice president, Late Development Oncology, Johnson & Johnson Innovative Medicine. “These results further support the potential of TAR-210 with quarterly administration as a bladder-sparing and BCG-free treatment option, underscoring our deep commitment to pioneering novel therapies for patients who face limited treatment avenues.”

“At Johnson & Johnson, we are committed to transforming bladder cancer treatment with novel drug delivery technology and precision-based therapies,” said Henar Hevia, senior director, EMEA Therapeutic Area Lead, Oncology at Johnson and Johnson Innovative Medicine. “As the data continues to mature, it is encouraging to see sustained positive responses to treatment. We look forward to investigating the full potential of TAR-210 in patients with FGFR-altered non-muscle invasive bladder cancer through an ongoing and comprehensive clinical development programme.”

Europe has one of the highest rates of bladder cancer in the world, with nearly 225,000 patients diagnosed in 2022, a 10% increase from 2020. NMIBC constitutes approximately 75% of all newly diagnosed bladder cancers. Currently, adjuvant intravesical immunotherapy with BCG or intravesical chemotherapy is the standard of care for patients with intermediate- and high-risk NMIBC. Between 30- 40% of patients do not respond to BCG, facing disease recurrence or progression. In such scenarios of HR-NMIBC, radical cystectomy (removal of the bladder) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.

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