New advances in the treatment of bladder cancer: from monotherapy to intravesical devices

In 2022, Europe had one of the highest rates of bladder cancer in the world, with almost 225,000 patients diagnosed, an increase of 10 percent on 2020. Cases of non-muscle bladder cancer Invasive infections account for approximately 75 percent of new diagnoses. Although immunotherapy using Bacillus Calmette-Guérin (BCG) has been the standard treatment for nearly five decades, 30 to 40 percent of patients do not respond to this treatment and experience disease relapse or progression.

These data highlight the need to develop new treatments that improve patients’ quality of life and promote their recovery. In this spirit, Johnson & Johnson presented the results of two innovative treatments for bladder cancer at the American Urological Association (AUA) Annual Congress.

TAR-200 monotherapy

The company announced updated results from Cohort 2 of the Phase 2b SunRISe-1 study examining the efficacy and safety of the investigational device. TAR-200 as monotherapy in patients with high-risk non-muscle-invasive bladder cancer. These patients do not respond to BCG therapy and have carcinoma in situ and are unsuitable for or reject radical cystectomy.

The study results included an evaluation of 85 patients receiving TAR-200 as monotherapy, with a mean age of 71 years, and 32.9 percent had concomitant papillary disease. the complete response (CR) rate confirmed by central review was 82.8 percent., according to urine cytology and/or biopsy. The estimated duration of response (DDR) at one year was 74.6 percent, with a median follow-up of 29.9 weeks for responding patients; At the last data cutoff in January 2024, 85 percent of responding patients had maintained their LPO, and none had developed muscle-invasive bladder cancer or metastases. 98 percent complete response was achieved at the first disease assessment at week 12; and four of five patients who completed two years of treatment were still CR.

They registered treatment-related adverse events (AEs)

in 61 patients. The most common were urinary frequency (35.3 percent), dysuria (29.4 percent), urinary urgency (15.3 percent), and urinary tract infection (15.3 percent).

Intravesical device TAR-210

On the other hand, Johnson & Johnson also published updated results from an open-label, multicenter, multiarm, Phase I study examining the safety and efficacy of TAR-210. This intravesical targeted release device is designed to provide Local and sustained release of erdafitinib in the bladder in patients with non-muscle-invasive bladder cancer. which are certain changes in the fibroblast growth factor receptor (FGFR).

In this case, the results included updated data from patients with non-muscle-invasive bladder cancer. high risk (high grade Ta/T1, papillary only), recurrent and non-responsive to BCG, rejecting radical cystectomy or not a candidate for radical cystectomy, belonging to cohort 1. Results from another cohort, which includes patients with recurrent non-muscle-invasive cancer bladder intermediate risk (Ta/T1) with low-grade papillary disease left in situ as a tumor marker.

At the last data cutoff in March 2024, a total of 64 patients were treated with TAR-210 across the two cohorts. Of the 21 patients in cohort 1 The disease-free survival rate was 90 percent.

. As for the other group, where 31 patients were evaluable for efficacy, it was observed that 28 out of 31 patients achieved a complete response (CR) rate of 90 percent.

The most common treatment-related AEs were grade 1/2 in the lower urinary tract. No dose-related toxicity was observed and no treatment-related deaths were reported.

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