On October 22, 2023 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that data from the Phase 2b SunRISe-1 study evaluating the efficacy and safety of TAR-200 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for, or decline, radical cystectomy, showed that 77 percent of patients (23 out of 30 [95 percent Confidence Interval (CI), 58-90]) achieved a complete response (CR) (Press release, Johnson & Johnson, OCT 22, 2023, https://www.prnewswire.com/news-releases/tar-200-intravesical-delivery-system-results-show-77-percent-complete-response-rate-in-patients-with-bacillus-calmette-guerin-unresponsive-high-risk-non-muscle-invasive-bladder-cancer-301963786.html [SID1234636222]). These data were featured today in a Late-Breaking Mini-Oral Presentation Session (Abstract #LBA105) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Congress taking place October 20-24 in Madrid, Spain.1

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TAR-200 is an investigational intravesical drug delivery system designed to provide sustained local release of gemcitabine into the bladder. Interim results from the SunRISe-1 study were featured earlier this year at the American Urological Association Annual Meeting. Results presented today included an evaluation of 54 patients (median age of 71; range 40-85; 33 percent with concurrent papillary disease) who received TAR-200 monotherapy. Centrally confirmed CR by urine cytology and/or biopsy was achieved in 23 of 30 patients (CR 77 percent; 95 percent CI, 58-90) and investigator-confirmed CR was achieved in 24 out of 30 patients (CR 80 percent; 95 percent CI, 61-92). Twenty-one out of 23 responders had ongoing CR with 11 patients maintaining their CR for six months or more, and six patients had ongoing CR for 12 months or more. Median duration of response (DOR) was not reached.

Treatment-related adverse events (TRAEs) occurred in 29 patients (54 percent). The most common (≥10 percent) were pollakiuria, dysuria, micturition urgency, and hematuria. Four patients (seven percent) had Grade 3 or higher TRAEs and one patient (two percent) had serious TRAEs. Two patients (four percent) had TRAEs leading to discontinuation and no deaths were reported.

"Patients with NMIBC, who are unresponsive to BCG treatments, are at high risk for disease progression, and unfortunately, available treatment options remain limited," said Andrea Necchi,* M.D., of Italy’s Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute and a presenting author of the study. "The results of TAR-200 observed in this study present a potential less-invasive option for patients in the future."

"The current treatment options for patients with HR-NMIBC, who are unresponsive to BCG, remain limited and typically include repeated BCG therapy or radical cystectomy," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Janssen Research & Development, LLC. "Our goal is to transform the treatment landscape for patients with bladder cancer through innovative approaches that focus on bladder preservation and long-term survival."

Bladder cancer is the tenth most common cancer worldwide, with more than 600,000 patients diagnosed each year, and more than 200,000 new cases every year across Europe alone.2

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 decline, radical cystectomy. Participants are randomized to one of three cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1), TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3). 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 June 1, 2023.

About TAR-200
TAR-200 is an investigational drug delivery 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 and NMIBC in SunRISe-1 and SunRISe-3.

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. 3, 4 HR-NMIBC makes up 15–44 percent 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 percent cancer-specific survival if performed before muscle-invasive progression.5,6 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.7 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.