Johnson & Johnson announced positive results from the Phase 2b SunRISe-1 study, evaluating TAR-200 for patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). The data, presented at the European Society of Medical Oncology (ESMO) 2024 Congress, highlight the potential of TAR-200 as a novel treatment option for this patient population.
High Complete Response with TAR-200 Monotherapy
In the pivotal Cohort 2 of the SunRISe-1 study, TAR-200 monotherapy demonstrated a high, centrally-confirmed complete response (CR) rate of 83.5% (95% CI: 74-91) in all 85 enrolled patients. These results indicate a significant clinical benefit for patients who have failed BCG treatment, a standard immunotherapy for HR-NMIBC.
Michiel S. van der Heijden, M.D., Ph.D., a medical oncologist at the Netherlands Cancer Institute, stated, "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. 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."
Durable Responses and Safety Profile
The study also revealed highly durable CRs without the need for reinduction. After a median follow-up of 9 months, 82% of patients maintained their response, with an estimated 12-month CR rate of 57.4% based on the Kaplan-Meier curve. The overall risk-benefit profile favors TAR-200 monotherapy in this patient population.
Low discontinuation rates due to treatment-resistant adverse events (TRAEs) were observed with TAR-200 (6%). The most common TRAEs across Cohorts 1 and 2 were pollakiuria, dysuria, hematuria, and urinary tract infection. No treatment-related deaths were reported.
Combination Therapy and Cetrelimab Monotherapy
First results from Cohort 1 (TAR-200 plus cetrelimab) showed a 67.9% centrally-confirmed CR (95% CI, 54-80). Cetrelimab monotherapy (Cohort 3) showed a 46.4% 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.
About TAR-200
TAR-200 is an investigational targeted releasing system designed for extended local release of gemcitabine into the bladder. It is administered in a physician's office setting during a brief procedure without anesthesia. The FDA granted TAR-200 Breakthrough Therapy Designation in December 2023 for BCG-unresponsive HR-NMIBC patients ineligible for or electing not to undergo radical cystectomy.
Unmet Need in Bladder Cancer Treatment
Bladder cancer is the ninth most common cancer worldwide. While BCG immunotherapy is a standard treatment, 30-40% of patients do not respond and may require radical cystectomy, a major surgery with significant morbidity. TAR-200 offers a potential alternative for these patients, addressing a critical unmet need.
Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Innovative Medicine, Johnson & Johnson, said, "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."
