Unmet needs in high risk NMIBC

Bladder cancer is a challenging and recurrent disease that significantly impacts both those experiencing it and those providing care. Its management demands ongoing surveillance and frequent interventions, making it particularly challenging for patients. When the cancer penetrates the deeper muscle layers of the bladder, the risk of it spreading beyond the bladder increases dramatically, heightening the threat of severe outcomes, including death. For this reason, a timely and structured therapeutic approach is essential—especially for those with high-risk, non–muscle-invasive forms of the disease.

In cases where the disease becomes unresponsive to BCG therapy, treatment becomes even more complex. Patients in this category have typically undergone multiple rounds of intravesical therapy without success. Historically, the standard response was surgical removal of the bladder to prevent further progression and metastasis. However, emerging therapies have shown promise in controlling tumor growth even after BCG failure, offering new hope and potentially changing the course of treatment for this difficult condition.

Surgical removal of the bladder, known as radical cystectomy, remains a highly invasive and risky procedure. Despite being performed at experienced centers, it carries a 30% to 50% complication rate, notable readmission rates, and a perioperative mortality risk of approximately 2%. Moreover, it has a lasting psychological and quality-of-life impact on patients. With the development of newer, more effective therapies, there is increasing potential to delay or avoid this operation in select patients. While surgery is still necessary in some cases, current trends suggest a shift toward managing the disease less invasively for as long as possible.