Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive
Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE:JNJ) announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA85).
"The safety and efficacy profile observed across multiple patient cohorts in the SunRISe-1 study further supports the potential of TAR-200 for patients with high-risk non-muscle-invasive bladder cancer as an innovative targeted releasing system," said Michiel S. van der Heijden, M.D., Ph.D., medical oncologist at Netherlands Cancer Institute. "These results support the potential of this novel treatment approach for patients who are not responsive to BCG immunotherapy and who face life-altering options, such as radical cystectomy."
Pivotal Cohort 2 (TAR-200 monotherapy):
New results from all 85 patients enrolled in the pivotal cohort show a high, centrally-confirmed, single-agent complete response (CR) rate of 83.5 percent (95 percent confidence interval [CI], 74-91). Results show highly durable CRs without the need for reinduction, with 82 percent of patients maintaining response after a median follow-up of 9 months, and an estimated 12-month CR rate of 57.4 percent based on the Kaplan-Meier curve. The overall risk-benefit profile favors TAR-200 monotherapy (Cohort 2) in this patient population.1 Earlier results from Cohort 2 were previously presented at the 2024 American Urological Association (AUA) Annual Meeting.
Cohorts 1 and 3 (TAR-200 plus cetrelimab [CET] and CET monotherapy, respectively):
First results from Cohort 1 showed a 67.9 percent centrally-confirmed CR (95 percent CI, 54-80; 28-66, respectively). The first results from Cohort 3 (CET monotherapy) showed a 46.4 percent centrally-confirmed CR. The overall risk-benefit profile favors TAR-200 monotherapy (Cohort 2) in this patient population. The CET monotherapy CR rate is numerically similar to previously published CR rates from this class of therapies.1
"Our mission, to stay in front of cancer, drives us to innovate in ways that truly redefine treatment paradigms for patients with bladder cancer," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Innovative Medicine, Johnson & Johnson. "The data from our SunRISe clinical program illuminate the possibility of an innovative approach in an outpatient setting with the potential to impact patient well-being and enhance the entire treatment experience."
Low discontinuation rates due to treatment-resistant adverse events (TRAEs) were seen with TAR-200 (Cohort 2, six percent) and CET (Cohort 3, seven percent) alone, with higher rates in the combination (Cohort 1, TAR-200 26 percent or CET 23 percent). The most common (>20 percent) TRAEs of any grade across Cohort 1 and 2 were pollakiuria, dysuria, hematuria and urinary tract infection. No treatment-related deaths were reported.1
Source: PRNewswire. (2024). New Data from TAR-200 Phase 2b SunRISe-1 Study Show 84 Percent Complete Response Rate in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer [Press release]. https://www.prnewswire.com/news-releases/new-data-from-tar-200-phase-2b-sunrise-1-study-show-84-percent-complete-response-rate-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer-302248316.html#financial-modal.
Related Content:
ESMO 2024: TAR-200 +/- Cetrelimab and Cetrelimab Alone in Patients with BCG-Unresponsive High-Risk NMIBC: Updated Results from SunRISe-1