TARIS Biomedical has partnered with Bristol-Myers Squibb to undertake a Phase lb clinical trial of TAR-200 (GemRIS) in combination with Opdivo (nivolumab) in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy.
The trial will examine the safety, tolerability, and preliminary efficacy of TAR-200 and Opdivo combination to treat MIBC.
Bladder cancer is estimated to affect more than 2.7 million patients worldwide.
The disease is one of the most expensive types of cancers to treat on a per-patient lifetime basis. With fewer options for treatment, bladder cancer often may metastasise and lead to death.
TARIS Biomedical president and CEO Purnanand Sarma said: “This is the first study evaluating the potential benefits of combining TAR-200 with a systemically administered immune checkpoint inhibitor.
“MIBC is a potentially lethal disease with high unmet clinical need.”
TARIS has been developing the TAR-200 product to release the chemotherapeutic agent gemcitabine continuously in the bladder over seven days.
The company’s TARIS System is designed to continuously release drugs in the bladder over weeks to months.
Opdivo has been developed by Bristol-Myers Squibb to harness the patient body’s own immune system to help restore anti-tumour immune response to fight cancer.
The programmed death-1 (PD-1) immune checkpoint inhibitor has already become an important treatment option across multiple cancers.
In addition to the latest clinical trial collaboration, Bristol-Myers Squibb has made an equity investment in TARIS.