Johnson & Johnson announced updated results from Cohort 2 of the Phase 2b SunRISe-1 study evaluating the efficacy and safety of investigational TAR-200 monotherapy in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, who are ineligible for, or decline, radical cystectomy. These data were featured in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place May 3-6, 2024, in San Antonio, Texas. The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI, 70.6-91.4).

The study protocol did not allow retreatment for nonresponders, consistent with U.S. Food and Drug Administration (FDA) guidance. The estimated 1-year duration of response (DOR) rate is 74.6% (95% CI, 49.8-88.4), with median follow-up in responders of 29.9 weeks (range, 14-140); 90% (47 of 48) of CRs were achieved at first disease assessment at week 12, and four of five patients who have completed two years of treatment remain in CR. The investigator-assessed confirmed CR rate correlated strongly with central results.

Interim results from the SunRISe-1 Study were featured at the European Society for Medical Oncology 2023 Congress and shared at AUA 2023. These results were also presented at the European Association of Urology 2024 Congress. Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.

TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with BCG-un responsive HR-NMIBC, who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder). This major abdominal procedure requires a urinary diversion to be created to collect and store urine.

SunRISe-1 (NCT04640623) is a randomized, parallel-assignment, open-label Phase 2 clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for, or elected not to undergo, radical cystectomy. TAR-200 is a randomized, parallel- assignment, open-label Phase2 clinical study evaluating the safety and safety of investigational Tar-200 in combination with cETrelimab, TAR - TAR-200 alone, and cetrelimab alone For BCG-unresponsive HR -NMIBC carcinoma in situation (CIS) patients who is ineligible for, or elected not To undergo, radical cystectomy (s surgical removal of the bladder). This large abdominal procedure requires a urinary diversion To be created to collect and store urinary diversion to be created to collected and store urine.

SunRise-1 (NCT04740623) is a randomized. SunRISe- 1 (NCT04640623), is a randomized, parallel-Assignment, open-label Phase 1 clinical study evaluating the safety and effectiveness of TAR-200 in addition with cetrelimab. TAR-200 in combination With cetrelimab, tAR-200 alone, or Cetrelimab alone forBCG-unresponsive HR- NMIBC carcinoma in situ in situ (CIS) Patients who are ineligible for, or election not to undergo, radical cySTectomy.