The trial will assess the safety, tolerability, and preliminary efficacy of their combination therapy in MIBC patients who are scheduled for radical cystectomy.
TAR-200, which is the lead investigational program of Taris Biomedical in bladder cancer, has been designed to release gemcitabine, a chemotherapeutic agent in the bladder continuously over seven days.
Opdivo, on the other hand, is a programmed death-1 (PD-1) immune checkpoint inhibitor. It was designed to utilize the body’s own immune system to help rebuild anti-tumor immune response.
Opdivo had been approved in more than 60 countries including the US for treating certain types of cancers as a single agent and also in combination with other drugs.
Taris 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. We are excited to partner with Bristol-Myers Squibb, a world-leader in oncology, to advance approaches that may provide meaningful benefit to patients.”
Bristol-Myers Squibb oncology development head Fouad Namouni said: “We continue to explore multiple approaches to treating cancer as part of our broad research program focused on delivering the next wave of oncology therapies.
“Partnering with TARIS will allow us to advance our scientific understanding of combining Opdivo with continuous local chemotherapy as we seek to improve outcomes for patients with this aggressive form of bladder cancer.”
Image: Bristol-Myers Squibb facility in Syracuse, New York, US. Photo: courtesy of Bristol-Myers Squibb Company.