LEXINGTON, Mass. & NEW YORK--(BUSINESS WIRE)--TARIS Biomedical LLC, and Bristol-Myers Squibb (NYSE:BMY) today announced that the companies have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of TARIS’ investigational product, TAR-200 (GemRIS™), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b trial will evaluate the combination in patients with Muscle Invasive Bladder Cancer (MIBC) who are scheduled for radical cystectomy. In conjunction with this collaboration, Bristol-Myers Squibb also made an equity investment in TARIS.
Bladder cancer affects more than 2.7 million patients worldwide, and is among one of the most expensive types of cancers to treat on a per-patient lifetime basis. Few options are available to treat MIBC, which often may metastasize and leads to death.
“This is the first study evaluating the potential benefits of combining TAR-200 with a systemically administered immune checkpoint inhibitor,” said Purnanand Sarma, Ph.D., president and CEO of TARIS. “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.”
“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,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “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.”
About TARIS System and TAR-200 (GemRIS™)
The TARIS® System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. TAR-200 is TARIS Biomedical’s lead investigational program in bladder cancer, and is designed to release the chemotherapeutic agent gemcitabine continuously in the bladder over seven days.
About TARIS Biomedical®
TARIS Biomedical® is building a unique therapeutically-focused urology company, developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases. We are advancing therapies for debilitating conditions, including bladder cancer and overactive bladder, enabled by continuous local dosing where it is needed. www.tarisbiomedical.com
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
