Johnson & Johnson’s Janssen Pharmaceutical announced the first results from the open-label Phase 2 SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy and cetrelimab monotherapy in patients with Bacillus Calmette-Guerin- unresponsive high-risk non-muscle-invasive bladder cancer, who are ineligible for, or decline, radical cystectomy. The study demonstrated that 72.7% of patients treated with TAR-200 alone and 38.1% of patients treated with cetrelimab alone achieved the primary endpoint of a complete response. Preliminary results of the SunRISe-1 study included 23 evaluable patients in Cohort 2 and 24 evaluable patients in Cohort 3. After median follow-up of 10.6 months, 15 of 16 responses in Cohort 2 are still ongoing; median duration of response was not reached. Additionally, six of the patients in Cohort 2 maintained their response beyond 12 months and none of the complete responders had documented recurrence or progression. The initial findings from SunRISe-1 showed low rates of grade three or higher adverse events and a limited number of treatment discontinuations due to adverse events were observed with TAR-200, the company said. Reference Link
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