These data were featured today in a Late-Breaking Mini-Oral Presentation Session (Abstract #LBA104) at the
Results featured data from Cohort 1 [(C1); patients with recurrent, Bacillus Calmette-Guerin (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 intermediate-risk (IR) NMIBC (Ta/T1) low-grade papillary disease] left in situ as tumor marker lesions.
At the data cutoff of
The most common treatment-related adverse events (TRAEs) were Grade 1/2 lower urinary tract TRAEs. There were no dose-limiting toxicities and no deaths. Two patients discontinued the study due to TRAEs of low-grade urinary symptoms and one patient had serious TRAEs of pyelonephritis and sepsis. 'Patients with high- or intermediate-risk non-muscle-invasive bladder cancer have seen limited advancement in the treatment landscape over the last 50 years and the available options are associated with a high risk of recurrence and significant side effect burden,' said
'We are advancing this novel technology with the ambition of bringing bladder-sparing and BCG-free regimens to patients with localized bladder cancer,' said
About TAR-210
TAR-210 is an investigational erdafitinib intravesical delivery system. The safety and efficacy of TAR-210 is being evaluated in a Phase 1 study (NCT05316155) in patients with muscleinvasive bladder cancer (MIBC) and NMIBC. The study categorizes patients into four cohorts based on their disease presentation. Cohort 1 (C1) includes patients with recurrent, BCGunresponsive high-risk NMIBC with concomitant high-grade papillary disease who have refused or are ineligible for radical cystectomy (RC). Cohort 2 (C2) includes patients with the same presentation, but who are scheduled for RC. Cohort 3 (C3) includes patients with recurrent, intermediate-risk NMIBC with a history of low-grade papillary disease. To be eligible for C3, the presence of visible tumor(s) is required. Cohort 4 (C4) includes patients with muscle-invasive bladder cancer. The primary endpoint of the study is safety (adverse events, including dose-limiting toxicity). Secondary endpoints include pharmacokinetics (PK), RF survival in patients in C1 and C2, CR rate and duration of CR in patients in C3 and pathologic CR rate in C4.2
About Non-Muscle-Invasive Bladder Cancer
Non-muscle-invasive bladder cancer (NMIBC) is cancer found in the tissue that lines the inner surface of the bladder. The bladder muscle is not involved. Patients are categorized into one of three risk groups which describe how likely the cancer is to progress, spread further, or come back after treatment: low-risk, intermediate-risk or high-risk. Radical cystectomy is currently recommended for NMIBC patients who fail Bacillus Calmette-Guerin (BCG) therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.3,4 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.5 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-210 or erdafitinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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