LEXINGTON, Mass., Nov. 9, 2018 /PRNewswire/ -- TARIS® announced today the presentation of data detailing the natural history of patients with Muscle Invasive Bladder Cancer (MIBC) who do not receive potentially curative therapy. This research leveraged 17 years of longitudinal data from Sweden's National Registry of Urinary Bladder Cancer (SNRUBC) and BladderBaSe disease registries. It was the result of a collaboration between TARIS, Professor Per-Uno Malmström, and Uppsala Clinical Research Center (previously announced here). The research is being presented as a late breaking poster at the 10th European Multidisciplinary Congress on Urological Cancers in Amsterdam, The Netherlands.
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% did not undergo radical cystectomy, the preferred standard of care by U.S. and European guidelines. The poster, which focuses on patients not receiving potentially curative therapy and diagnosed with early stage, organ confined MIBC (cT2-cT3 disease, without nodal involvement or metastasis), shows:
- Median overall survival was only 11.4 months
- Bladder cancer was the primary cause of death in more than 70% of patients, despite substantial comorbidities
- Patients experienced an average of 2.5 hospitalizations over the first 12 months following diagnosis
"Radical cystectomy and other potentially curative therapies are serious and invasive interventions. It is well known that a number of patients are unfit to receive these therapies, due to age, frailty, and other underlying medical conditions, despite their potential benefit," said Dr. Christopher Cutie, M.D., MBA, Chief Medical Officer of TARIS. "To our knowledge, the research presented by Dr. Malmström 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."
"TARIS is committed to building a better understanding of this population and developing new approaches to manage this lethal disease," said Purnanand Sarma, Ph.D., President and CEO of TARIS. "Our TAR-200 program has been granted Fast Track designation by the FDA for the treatment of patients with organ confined or locally advanced MIBC, who are unfit for curative intent therapy. This program is currently in ongoing clinical trials in the U.S. and in Europe, and we are dedicated to rapidly advancing this therapy to the patients."
About Muscle Invasive Bladder Cancer (MIBC)
Bladder cancer is the fifth most common neoplasm in industrialized countries, affecting roughly 2.7 million people worldwide. In the United States, the National Cancer Institute estimates there will be approximately 81,000 new cases and over 17,000 deaths in 2019i; muscle invasive bladder cancer (MIBC) accounts for 20-25% of the newly diagnosed cases, and the majority of disease-related mortality.
While some potentially curative treatments, including surgical organ removal and chemoradiation, are available, 40% or more of US patients with MIBC are unfit to undergo these morbid procedures, or opt to not receive them.ii Available treatment options for these patients are limited to palliative care.
About TARIS Bio™
TARIS Bio is developing transformational therapies to treat people with debilitating urological disorders. The company is unlocking novel epithelial biology through continuous disease engagement with its unique platform. TARIS' lead programs in bladder cancer and overactive bladder position the company to improve patient health and redefine urologic care.
About Uppsala Clinical Research Center (UCR)
UCR's mission is to improve human health in Sweden and worldwide. UCR has the competence and technology necessary to transform innovative ideas into translational research projects, clinical studies, and registry-based improvement projects. UCR is organized as an independent, non-profit research center affiliated with Uppsala University and Uppsala University Hospital.
About SNRUBC and BladderBaSe
Swedish National Register of Urinary Bladder Cancer (SNRUBC) was initiated in 1997. It is a nationwide register with detailed information on 97% of bladder cancer cases in Sweden as compared with the Swedish Cancer Register. Recently the SNRUBC was linked to other national healthcare and demographic registers into the Bladder Cancer Data Base Sweden (BladderBaSe).
i National Cancer Institute. Surveillance, Epidemiology, and End Results Program: Turning Cancer Data Into Discovery. Cancer of the Urinary Bladder. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed November, 2018.
ii Gray, PJ. et al. Eur Urol, 2013, 63(5), 823 - 829