Johnson & Johnson has announced positive results from its Phase 2b SunRISe-1 study, evaluating TAR-200 for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). The data indicate a high complete response rate and durable efficacy, offering a potential new treatment option for this challenging patient population.
High Complete Response Rate Observed
Results from all 85 patients enrolled in the pivotal cohort of the SunRISe-1 study showed a centrally-confirmed, single-agent complete response (CR) rate of 83.5%. This indicates a significant proportion of patients experienced complete eradication of their cancer following treatment with TAR-200.
Durable Responses Without Reinduction
An important aspect of the study is the durability of the observed responses. Data showed that 82% of patients who achieved a complete response maintained it after a median follow-up of 9 months. Furthermore, the estimated 12-month CR rate was 57.4%, based on Kaplan-Meier curve analysis, suggesting a sustained treatment effect over time. This is particularly relevant as it demonstrates the potential for long-term disease control without the need for repeated treatment cycles.
Comparison with Other Treatment Approaches
The SunRISe-1 study also included cohorts treated with CET monotherapy. First results from Cohort 1 showed a 67.9 percent centrally-confirmed complete response. The first results from Cohort 3 (CET monotherapy) showed a 46.4 percent centrally-confirmed complete response. The company stated that the overall risk-benefit profile favors TAR-200 monotherapy (Cohort 2) in this patient population and that the CET monotherapy complete response rate is numerically similar to previously published complete response rates from this class of therapies.
These findings suggest that TAR-200 monotherapy may offer a more favorable risk-benefit profile compared to CET monotherapy in this patient population.
