J&J's TAR-200 Monotherapy Delivers Over 80% Disease-Free Survival In High-Risk NMIBC Patients

(RTTNews) - Johnson & Johnson (JNJ) announced first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer. The results showed the promise of TAR-200 in the patient population with more than an 80 percent disease-free survival (DFS) rate without the need for reinduction and 94 percent of patients able to preserve their bladder.

The high disease-free survival and bladder preservation rate combined with the well-tolerated safety profile in these patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1) show the potential of TAR-200 as a meaningful alternative to surgery.

According to the company, the first results of this interim analysis from Cohort 4 of the SunRISe-1 study demonstrated 85.3 percent and 81.1 percent DFS rates at six and nine months, respectively, in patients with BCG-unresponsive, HR-NMIBC with papillary-only disease treated with TAR-200 monotherapy. These high DFS rates are particularly encouraging given the significant risk of recurrence in this population.

Among patients with high-grade Ta and T1 disease, DFS rates remained consistently strong—85.7 percent and 84.7 percent at six months, and 82.1 percent and 79.4 percent at nine months, respectively. The strong DFS across both subtypes—despite their differing depths of invasion—underscores the potential of TAR-200 to deliver sustained tissue penetration. Notably, 94.2 percent of patients avoided radical cystectomy at median follow-up of 12.8 months.

The early progression-free and overall survival rates of 95.6 percent and 98 percent at nine months, respectively, are reassuring as disease progression or death were highly uncommon among patients treated with TAR-200. While 12-month DFS data is not yet mature, these preliminary findings show that TAR-200's sustained intravesical gemcitabine delivery may potentially offer durable disease control while minimizing the need for invasive procedures.

These results support continued evaluation in the ongoing Phase 3 SunRISe-5 study, comparing TAR-200 to chemotherapy in patients with BCG-pretreated, papillary-only HR-NMIBC.

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