These data were featured today in a plenary session (Abstract #P2-01) at the 2024
'The high complete response rate and durability of these responses observed in patients treated with TAR-200 underscores the potential of this treatment approach for patients with BCG-unresponsive HR-NMIBC,' said
Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy. 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
Interim results from the SunRISe-1 study were featured at the
Treatment-related adverse events (TRAEs) occurred in 61 patients (71.8%). The most common (10%) were pollakiuria (35.3%), dysuria (29.4%), micturition urgency (15.3%), and urinary tract infections (15.3%). Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs. Four patients (4.7%) had TRAEs leading to discontinuation and no deaths were reported.
'These study results mark a significant step in our mission to bring new treatment options to patients that focus on bladder preservation and long-term survival,' said
TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician's office setting during a 3- to 5-minute procedure with no anesthesia. In
Bladder cancer is the sixth most common cancer in the
About SunRISe-1
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. Participants are randomized to 1 of 4 cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1), TAR-200 alone (Cohort 2), cetrelimab alone (Cohort 3), or TAR-200 alone with papillary disease only (Cohort 4). The primary endpoint is CR rate at any time point. Secondary endpoints include DOR, overall survival, pharmacokinetics, quality of life, safety and tolerability. Cohorts 1 and 3 were closed to further enrollment effective
About TAR-200
TAR-200 is an investigational targeted releasing system, enabling controlled release of gemcitabine into the bladder, increasing the amount of time the drug delivery system spends in the bladder and sustaining local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 and SunRISe-4, NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5.
About Cetrelimab
Administered intravenously, cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens across the Janssen Oncology portfolio.
About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.6,7 HR-NMIBC makes up 15-44% of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, and CIS. Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90% cancer-specific survival if performed before muscle-invasive progression.8,9 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.10 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.6,10
About
At
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200 or cetrelimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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