NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) 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 (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
The company noted that new results from all 85 patients enrolled in the pivotal cohort show a high, centrally-confirmed, single-agent complete response (CR) rate of 83.5 percent. Results show highly durable CRs without the need for reinduction, with 82 percent 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 (Cohort 2) in this patient population.
According to the company, 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 overall risk-benefit profile favors TAR-200 monotherapy (Cohort 2) in this patient population. The CET monotherapy complete response rate is numerically similar to previously published complete response rates from this class of therapies.
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