By Fineline Cube 
US giant Johnson & Johnson (J&J; NYSE: JNJ) has released the first results from Cohort 4 of the Phase IIb SunRISe-1 study, assessing TAR-200, an intravesical gemcitabine releasing system, in patients with certain types of bladder cancer. Preliminary findings indicate that TAR-200 achieved a disease-free survival rate (DFS) of over 80%, with no reinduction required and 94% of patients able to preserve their bladder. In patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1), TAR-200’s high DFS and bladder preservation rate, combined with its well-tolerated safety profile, highlight its potential as a meaningful alternative to surgery.
Safety Profile and Adverse Events
Among the 52 patients enrolled in the study, TAR-200 monotherapy demonstrated a safety profile consistent with prior studies, with no new safety signals observed. Most treatment-related adverse events (TRAEs) were low grade and resolved quickly, with a median duration of 3.7 weeks. Common TRAEs included dysuria (40.4%), pollakiuria (30.8%), and urgency (26.9%). Grade ≥3 TRAEs occurred in 13.5% of patients, most frequently bladder pain (3.8%). Three patients (5.8%) experienced serious TRAEs, and only four (7.7%) discontinued treatment due to TRAEs. Importantly, no treatment-related deaths were reported.
Regulatory Milestones
TAR-200, an investigational intravesical gemcitabine releasing system, was filed for marketing in the US in January of this year. The drug was awarded Breakthrough Therapy Designation (BTD) in December 2023 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with carcinoma in situ (CIS) who are ineligible for or have elected not to undergo radical cystectomy.-Fineline Info & Tech