A five-year long-term extension study of the Phase 2b OPTIMA II trial, published in Clinical Genitourinary Cancer, demonstrated durable complete responses (CRs) in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) treated with ZUSDURI (mitomycin) intravesical solution. Patients who initially achieved a CR remained event-free for a median of two years, and those who entered the long-term extension study (n=17) experienced a median response duration of 3.5 years. The study focused on a recurrent patient population (94% of the long-term cohort).
This data is particularly relevant because LG-IR-NMIBC is a chronic condition often necessitating repeated surgical interventions. The demonstrated durability of ZUSDURI’s effects offers a potentially valuable non-surgical alternative, especially for patients with recurrent disease, reducing the need for multiple surgeries and potentially improving quality of life. This offers a significant advancement in treatment options for this patient population.
Of the 41 patients who achieved a CR at three months post-ZUSDURI treatment in the OPTIMA II trial, 25 maintained CR at 12 months, and 17 continued into the long-term follow-up. The median duration of response was 24.2 months for the initial 41 patients and 42.1 months for the long-term cohort. Safety data specific to the long-term follow-up were not collected; however, the parent OPTIMA II study indicated common adverse events such as dysuria, pollakiuria, hematuria, urinary urgency, urinary tract infections, and fatigue.
This long-term data reinforces the potential of ZUSDURI to provide sustained remission in LG-IR-NMIBC, offering a less invasive and potentially more convenient treatment option for patients and physicians. This could lead to a shift in the treatment paradigm for LG-IR-NMIBC, favoring a non-surgical approach, particularly for recurrent cases, and potentially improving long-term outcomes for patients. Further research and real-world data will be essential to fully assess the impact of ZUSDURI on clinical practice.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
