Researchers Shed Light on Bladder Cancer Population Not Receiving Curative Intent Therapy

Patients experience a substantial disease-specific morbidity, are hospitalized frequently over their final year of life, and die primarily from bladder cancer progression

LEXINGTON, Mass. – Sept. 18, 2019 – Bladder cancer is the fifth most common cancer in industrialized countries, affecting roughly 2.7 million people worldwide. Muscle-invasive bladder cancer (MIBC), an aggressive and potentially lethal form of the disease, affects between 20 and 25 percent of patients diagnosed each year.

While potentially curative treatments for MIBC are available, including radical cystectomy (surgical removal of the bladder) and radiotherapy, many patients are unfit to undergo these invasive and burdensome procedures. In the absence of these interventions, patients are known to experience substantial disease-specific morbidity and rapid mortality. To date, the natural history of untreated MIBC has not been systematically evaluated, contributing to a lack of awareness of this serious disease burden.

Using 17 years of longitudinal data from Sweden’s National Registry of Urinary Bladder Cancer (SNRUBC) and BladderBaSe disease registries, a team of researchers in Sweden, led by Professor Per-Uno Malmström, recently explored the natural history of this patient population and further validated the need for alternative treatment options. Their results have been accepted for publication in The Journal of Urology.

This research highlights the substantial disease burden posed by MIBC, and the serious consequences of failure to receive potentially curative therapies. The analysis included nearly 10,000 patients and revealed that 57 percent did not undergo radical cystectomy, the preferred standard of care by U.S. and European guidelines. The data demonstrate that:

• Median overall survival was only 8 months
• Bladder cancer was the principal cause of death in 63 percent of patients, despite substantial pre-existing comorbidities
• Patients experienced a median of 2.1 hospitalizations over the first 12 months following diagnosis, for a total of 18.8 days in hospital

“It is well known that a number of patients are unfit to receive radical cystectomy and other potentially curative therapies due to age, frailty, and other underlying medical conditions, despite their potential benefit. This research is the first detailed examination of the patient experience that also highlights the significant lack of options that patients face if they are unable to receive these therapies,” said Dr. Malmström, Professor Emeritus of the Department of Surgical Sciences in Urology, Uppsala University.

These data showcases the devastating impact of MIBC in the absence of curative intent therapy. These patients experience higher hospitalization rates and longer hospital stays well above the Swedish national average. They also undergo a substantial rate of invasive procedures to manage disease progression, but still die primarily from bladder cancer progression.

A subset analysis was conducted on more than 1,300 patients with documented organ confined MIBC (T2-T3 M0). This represents a less advanced form of the disease which should be more amenable to curative treatment, if it were feasible. Despite this earlier disease stage, median overall survival was still less than one year. These patients were also hospitalized more frequently (2.4 hospitalizations per patient) and had higher rates of disease-specific mortality than the broader population.

TARIS Bio™ is committed to advancing a better understanding of this patient population, developing new therapeutic approaches to manage this potentially lethal disease, and providing funding for this research. The TAR-200 system releases the chemotherapeutic agent gemcitabine continuously in the bladder for multiple weeks. The program has been granted Fast Track designation by the U.S. Food and Drug Administration for the potential treatment of MIBC patients unfit for curative-intent therapy. This program is currently in ongoing clinical trials in the U.S. and Europe; a Phase 1b study has enrolled 34 MIBC patients unfit for potentially curative therapies.