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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