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Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of non-muscle invasive bladder cancer (NMIBC) per year, 54% are considered low grade (LG). While there is a low risk of progression and mortality in this population, chronically relapsing disease remains a pervasive problem. In patients who recur, it is estimated that 68% will experience 2 or more recurrence episodes throughout the course of their disease.

The current standard of care for treating patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a surgical procedure known as transurethral resection of bladder tumor (TURBT). Due to a lack of treatment options to reduce recurrences in these patients, they are typically managed with repeated TURBT for each subsequent recurrence. Repeated TURBT procedures can impact patients’ physical health and quality of life and are even associated with an increased risk in mortality. Due to the high disease recurrence rates, LG-IR-NMIBC patients will likely need multiple TURBTs over the course of their lifetime, leaving them more prone to these surgical burdens.

There are currently no drugs approved by the U.S. FDA for the treatment of recurrent LG-IR-NMIBC. If approved, UGN-102 will become the first medicine for this patient population.

Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of non-muscle invasive bladder cancer (NMIBC) per year, 54% are considered low grade (LG). While there is a low risk of progression and mortality in this population, chronically relapsing disease remains a pervasive problem. In patients who recur, it is estimated that 68% will experience 2 or more recurrence episodes throughout the course of their disease.

The current standard of care for treating patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) is a surgical procedure known as transurethral resection of bladder tumor (TURBT). Due to a lack of treatment options to reduce recurrences in these patients, they are typically managed with repeated TURBT for each subsequent recurrence. Repeated TURBT procedures can impact patients’ physical health and quality of life and are even associated with an increased risk in mortality. Due to the high disease recurrence rates, LG-IR-NMIBC patients will likely need multiple TURBTs over the course of their lifetime, leaving them more prone to these surgical burdens.

There are currently no drugs approved by the U.S. FDA for the treatment of recurrent LG-IR-NMIBC. If approved, UGN-102 will become the first medicine for this patient population.

Unmet need

Patients with low-grade upper tract urothelial cancer (LG-UTUC) are typically treated with kidney-sparing management, which includes endoscopic resection with or without intracavitary drug therapy. Kidney-sparing endoscopic surgery for small, solitary, low-grade tumors reduces the morbidity associated with radical surgery, without compromising oncological outcomes. However, endoscopic therapy is associated with high rates of local disease recurrence of about 50%-90% and requires lifelong surveillance, which can be associated with treatment-related complications such as ureteral stricture, perforation of the upper tract, bleeding, and infection. There remains a need for innovative and effective kidney-sparing approaches to LG-UTUC that avoid surgery, in turn reducing the likelihood of disease recurrence and improving patient outcomes. Over the past decade, research investigating the use of intravesical immunotherapy and chemotherapy agents for UTUC treatment has been challenged by the difficulty of achieving adequate dwell time, due to continuous urine production and drug dilution. This highlights a clinical need for an agent that conforms to the complex anatomy of the upper tract and demonstrates sufficient efficacy as well as durability of response for the treatment of LG-UTUC, either as adjuvant or primary therapy.

Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of NMIBC per year, high grade (HG) NMIBC represents approximately 30% of all NMIBC. Standard treatment for HG-NMIBC is transurethral resection of bladder tumors followed by adjuvant intravesical immunotherapy with Bacillus Calmette-Guérin (BCG). Unfortunately, a third of patients will not respond to BCG, and half of patients who initially respond to BCG will experience recurrence or progression. Radical cystectomy is strongly advocated in patients who are BCG‑refractory or relapse following BCG treatment due to the risk of invasive and metastatic disease, highlighting the need for nonsurgical treatment options in the setting of BCG failure.

Significant advances in the field of immunotherapy have found that immune checkpoint inhibitors like anti-CTLA-4 can harness the body’s natural immune defenses to combat cancer. When administered systemically, anti-CTLA-4 therapy has led to improved outcomes in patients suffering from advanced cancers. However, experience in a variety of advanced cancers has shown there are significant risks to immunotherapies administered systemically, including side effects that range from mild to potentially life-threatening. Such dose-limiting toxicity is currently preventing patients from benefiting from the full therapeutic potential of this promising agent.

Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of NMIBC per year, high grade (HG) NMIBC represents approximately 30% of all NMIBC. Standard treatment for HG-NMIBC is transurethral resection of bladder tumors followed by adjuvant intravesical immunotherapy with Bacillus Calmette-Guérin (BCG). Unfortunately, a third of patients will not respond to BCG, and half of patients who initially respond to BCG will experience recurrence or progression. Radical cystectomy is strongly advocated in patients who are BCG‑refractory or relapse following BCG treatment due to the risk of invasive and metastatic disease, highlighting the need for nonsurgical treatment options in the setting of BCG failure.

Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of NMIBC per year, high grade (HG) NMIBC represents approximately 30% of all NMIBC. Standard treatment for HG-NMIBC is transurethral resection of bladder tumors followed by adjuvant intravesical immunotherapy with Bacillus Calmette-Guérin (BCG). Unfortunately, a third of patients will not respond to BCG, and half of patients who initially respond to BCG will experience recurrence or progression. Radical cystectomy is strongly advocated in patients who are BCG‑refractory or relapse following BCG treatment due to the risk of invasive and metastatic disease, highlighting the need for nonsurgical treatment options in the setting of BCG failure.

Unmet need

Bladder cancers are described as muscle invasive or non-muscle invasive (NMIBC) based on whether they have invaded into the muscular layer of the wall of the bladder. Of the approximately 60,000 newly diagnosed cases of NMIBC per year, high grade (HG) NMIBC represents approximately 30% of all NMIBC. Standard treatment for HG-NMIBC is transurethral resection of bladder tumors followed by adjuvant intravesical immunotherapy with Bacillus Calmette-Guérin (BCG). Unfortunately, a third of patients will not respond to BCG, and half of patients who initially respond to BCG will experience recurrence or progression. Radical cystectomy is strongly advocated in patients who are BCG refractory or relapse following BCG treatment due to the risk of invasive and metastatic disease, highlighting the need for nonsurgical treatment options in the setting of BCG failure.