The bladder cancer treatment landscape is on the cusp of a significant transformation, fueled by recent approvals and ongoing clinical trials evaluating novel therapies. These advancements promise to address unmet needs and potentially reshape the standard of care for various stages of the disease.
Recent Approvals in Non-Muscle Invasive Bladder Cancer
According to Jason M. Hafron, MD, CMO of the Michigan Institute of Urology, the field is experiencing a surge of new treatments and indications. Two recent approvals have provided new options for patients with CIS-refractory non-muscle invasive bladder cancer who are cystectomy ineligible and have received adequate BCG therapy. These intravesical agents represent a significant step forward in managing this challenging patient population.
Challenges and Considerations for New Therapies
Dr. Hafron notes that the appropriate sequencing and utilization of these expensive agents pose a challenge for urologists. The approved indications are specific to CIS-refractory disease with or without papillary disease in patients who have received adequate BCG therapy, defined as at least 5 out of 6 induction therapies and 2 out of 3 maintenance therapies or 2 out of 6 inductions. Understanding these requirements is crucial for appropriate patient selection and reimbursement.
Investigational Agents in BCG-Naive Disease
Several clinical trials are exploring the combination of BCG with immune checkpoint inhibitors in BCG-naive patients with high-grade T1 CIS or high-grade TA bladder cancer greater than 3 centimeters. These trials, including the CREST, Merck 676 (pembrolizumab plus BCG), ALBAN, and POTOMAC trials, are evaluating whether the addition of a checkpoint inhibitor to BCG can decrease recurrence and progression rates. Results from these trials are anticipated to be available soon and could potentially change the standard of care for newly diagnosed, high-risk bladder cancer.
Novel Chemoablative Gel for Intermediate-Risk Bladder Cancer
UGN-102, a reverse thermal gel similar to that used in upper tract urothelial carcinoma, is under investigation for intermediate-risk bladder cancer. This chemoablative gel aims to ablate tumors and potentially reduce the need for repetitive TURBT procedures. While intermediate-risk bladder cancer is typically not life-threatening, it can impose a high therapeutic burden and risks associated with frequent TURBTs. UGN-102 represents an innovative approach to managing this condition.
Improving Outcomes with Checkpoint Inhibitors
Ongoing research is focused on improving the recurrence rate of BCG with checkpoint inhibitors. While BCG is effective, it is not perfect, with a high recurrence rate and a concerning progression rate. By adding a checkpoint inhibitor, researchers aim to improve recurrence-free rates and mitigate the challenges associated with BCG therapy. These trials hold the potential to significantly impact the standard of care if the results are positive.
