J&J announces additional results from pivotal Phase 2b SunRISe-1 study

Johnson & Johnson announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk non-muscle-invasive bladder cancer. New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology 2024 Congress. Pivotal Cohort 2: New results from all 85 patients enrolled in the pivotal cohort show a high, centrally-confirmed, single-agent complete response rate of 83.5%. Results show highly durable CRs without the need for reinduction, with 82% of patients maintaining response after a median follow-up of 9 months, and an estimated 12-month CR rate of 57.4 percent based on the Kaplan-Meier curve. The overall risk-benefit profile favors TAR-200 monotherapy in this patient population. Earlier results from Cohort 2 were previously presented at the 2024 American Urological Association Annual Meeting. Cohorts 1 and 3: First results from Cohort 1 showed a 67.9% centrally-confirmed CR. The first results from Cohort 3 showed a 46.4% centrally-confirmed CR. The overall risk-benefit profile favors TAR-200 monotherapy in this patient population. The CET monotherapy CR rate is numerically similar to previously published CR rates from this class of therapies. Low discontinuation rates due to treatment-resistant adverse events were seen with TAR-200 and CET alone, with higher rates in the combination. The most common TRAEs of any grade across Cohort 1 and 2 were pollakiuria, dysuria, hematuria and urinary tract infection. No treatment-related deaths were reported.